Quarterly News Report Summer 2009 Editor: Shirley Pearson
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EXECUTIVE NOTES
By Otis Archie
We all get off track sometimes and may even lose our way and that is ok. What is important is that we get back on track, identify the problems and work through them. Recently, I was at a SCORE meeting in Orange County and as I listened to the various businessmen discuss the many headaches and problems they are facing because of the down economy, I realized that lately because of my own personal issues with my mother’s illness, I was buying those reasons and accepting mediocrity. However something snapped inside of me and what was buried under the weight of responsibilities begin to grow… CONFIDENCE! Fellow owners, presidents, managers, engineers and entrepreneurs, we have been down this road before and we managed to work our way back to the top and we will again. My compass is set on emulating companies thriving and dealing with the world financial challenges and so should yours be. Isn’t it time we get our confidence back and find out what works and discard those things, ideas and people that do not?
So to those looking for a job, seek out companies that will demand your excellence. Keep your standards high; research the track records of the company and its leaders before you sign on the dotted line. It could mean the difference of being with a company for two years or ten years. Don’t lose confidence in your abilities and talents. To those looking to hire employees, remember just because the water seems full of fish does not mean they are all a good catch. Finding someone that will qualify your candidates to make sure they meet your standards is paramount at this time. Companies don’t fail… people do.
Together we can make a difference; Advance Medical Recruitment is about teamwork.
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2009 is well under way. Please send us any changes to your employment status and contact information so we can keep you updated and apprised of job opportunities. If we only had a dime for the amount of people that say they wished they heard about a missed opportunity.
Thanks to all of you that referred friends and cohorts last year. Any referral fees given; were given with a smile and a great deal of appreciation. Please continue referring people to us, as we love to work with people you know.
In my last posting I criticized The Wall Street Journal for its history of producing sophomoric and self-serving career advice. The newspaper publishes advertorials masquerading as articles. They are largely intended to drive readers to the Journal’s job listings. So much for editorial integrity.
But there is good advice to be had in lots of business publications. As I’ve pointed out, it’s not usually career advice. It’s guidance about business that can be readily applied to job hunting, hiring and career success. You just have to read between the lines and think.
An article in the January 19 edition of Fortune, How to manage your business in a recession, could easily have been re-cast as advice for managing your career in a recession. I won’t cover all 10 suggestions offered by Geoff Colvin, but I’ll try to show you how to translate some of them into useful career strategies.
Reset priorities to face the new reality. Colvin quotes a CEO who says companies have to abandon their strategic plans and deal with reality. As companies downsize massively and people with long career histories hit the street, too many will cling to their resumes and try to sell “who they are” so they can get another job like they had. Forget it. While it’s not impossible, the likelihood that you will find the same work you’ve always done is small. Your past experience is virtually meaningless now. However, your skills and abilities are even more paramount. But trying to apply them through your lifelong “strategic career plan” could ruin you. Face the new reality. And that reality is, what does a target company need, and how will you re-organize your skills and abilities to do a new kind of work? No company will figure that out for you. You must figure it out for yourself. Rather than planning the next step in your career, you must be able to cope with the shifting needs of the employers you want to work for. This idea is covered in detail in Richard Farson’s excellent Management of the Absurd. It’s a better career book than any career book.
Keep investing in the core. This is an important but overlooked tenet of business success that applies equally to career success. Thirty years ago, Tom Peters emphasized this idea in his book In Search of Excellence, but he referred to it as “sticking to the knitting.” Focus on what you do best, and get better at it. In an age where career writers love to pontificate about “what the hot jobs are” and people abandon their investments in themselves to chase what’s hot, the smart course is simple and compelling. Keep investing in what you do best and get better at it. We will all suffer in the downturn. But when the market turns back up, the winners will be those who are the best at what they do. The survivors. I’ll give you an example. I know expert mainframe computer programmers who were laughed at when pc’s and local area networks came to dominate corporate information technology. The smart ones didn’t abandon their core skills. While many of their cohorts ran toward the newest technologies, the mainframe guys (programmers in ancient languages like COBOL, APL, FORTRAN) cashed in on the never-ending demand for software maintenance and application-conversion engineering. They were the last men standing in their fields because they were the best. They earn top dollar today because they never stopped investing in their core skills. (I’m not knocking programmers who made the shift to new computer platforms and languages. But I’m crediting those who continued to develop core skills and made sure they were always “hot” — because “hot jobs” are only ephemeral.)
Your customers face new problems, so give them new solutions. I’m including this one because it’s a reprise of the “reset priorities” item above — and it puts a point on what matters most. What matters is the employer’s needs, not your resume. Job hunters waste tremendous energy trying to sell their resumes, to explain themselves, to promote their history, their credentials, their education, their accomplishments. Don’t defend your resume. Your resume is an old solution. Why do people expect a hiring manager to read a resume and figure out what to do with that package of history? Managers are lousy at that. Embattled employers don’t give a hoot what’s in your past if you can’t show them that you understand their problems — and show them how you will tackle them. Successful salespeople don’t talk about their products. They talk about a prospect’s problems.
Don’t look for help only where you’re told. Look where good ideas are, and use your noggin to apply them to your situation.
» Posted by Nick Corcodilos on January 16, 2009 at 1:00 pm
Mechanical Engineer
Researches, plans, and designs mechanical parts and assemblies for ventilator and related equipment by performing the following duties. Design of mechanical parts and assemblies for ventilator and related equipment. SolidWorks and AutoCad experience is mandatory. Design of pneumatic components and assemblies. Perform the fabrication and assembly of prototype parts, assemblies, and complete units.
Write the qualification and other test protocols. Perform engineering and qualification testing. Bachelor's degree or higher degree in engineering or physical science. Knowledge of standard mechanical drawing practices, CAD software; SolidWorks and AutoCad is mandatory.
Software Engineer
Researches, designs, and develops computer software for microprocessor systems for ventilators and related equipment. Research, design, and develop computer software from inception of project to end of project.
Write the qualifications and other test protocols. Perform engineering and qualification testing. Write specifications, provide appropriate materials for validation testing. Must be familiar with engineering equipment (i.e. scope, emulator, data acquisition). Manage a project from conceptual design to production release. Occasional travel may be required. Bachelor's degree or higher degree in software design, engineering, physical science, or mathematics
Quality Assurance Manager
Develops and maintains a system to assure that all products manufactured by the organization meets required specification and achieves superior quality and reliability levels. Assists the Director of Quality Assurance in all matters related to Quality, Compliance, Governmental and Operational activities. These would include the agencies of NIOSH, FDA, State DHS, ISO and Australian SAI Global. Ensure compliance with national and international standards and legislation. Identify and implement relevant quality-related training needs. Perform statistical analysis on processes and make recommendations for improvements as appropriate. Oversee, maintain and improve company ISO 9001: 2000 program. Troubleshoot and resolve product quality problems by researching problems, analyzing data and developing solution to problems. Bachelors in Engineering or Science Knowledge of regulatory requirement such as FDA. Experience in manufacturing and/or quality related field. Ability to effectively work with other department heads and upper management.
Quality Assurance Technician Support manufacturing and quality assurance groups to ensure quality product and compliance with quality system policies and procedures, FDA and international requirements, and ISO Standards for Class III Medical Devices. Examine and use prints, schematics, work instructions and procedures. Responsible for the maintenance of the NCMR program. Responsible for ensuring SPC data is accurate and collected in a timely manner. Assist in the analysis and reporting of SPC data. Assist in more complex inspection and verification of materials and product and associated documentation. Assist and perform quality systems training to company employees. Assist in the establishment of accept/reject limits for product. Assist and perform disposition, analysis, and reporting of deviations and NCMRs. Assist and perform trending and reporting of NCMRs, internal and external yields, and supplier corrective action. Qualifications: Bachelors degree, or Associates degree with 2 years related experience (medical device experience preferred), or equivalent. ASQ Certified Quality Technician (preferred). Knowledge of quality control and quality standards, handbooks, and specification. Sound working knowledge of computer software [Microsoft Word, Microsoft Excel] (required) along with various statistical programs [Minitab, SPSS, WinSPC] (preferred).
Senior Mechanical Engineer Senior R&D Mechanical Engineer with a proven track record of designing and developing a variety of medical devices or scientific instrumentation from concept through prototype and into production. The candidate shall be experienced in effectively managing interdisciplinary projects while working in an ISO 13485/FDA regulated environment, and be responsible for key product design and development work. The candidate shall have broad experience and demonstrated creativity and effectiveness in implementing materials and fabrication processes during the development of commercial medical devices, including injection molding, machining, welding, casting, and bonding of plastics, elastomers, metals, coating and plating, and other high and low volume manufacturing techniques. Also required is experience in developing protocols, measurements and tests, and design of experiments for development of medical devices and electromechanical devices. The candidate shall have experience in the integration of electronics, software, industrial design, and design for manufacturability of medical devices. Demonstrable proficiency with SolidWorks is required (Pro/E expertise may be substituted). Experience in performing engineering analysis and modeling such as stress-strain, heat transfer, fluid flow, and machine dynamics is desired. Must have a BS/MS in Mechanical Engineering and minimum of four years experience in the medical device industry and 8-10 years experience in electro-mechanical packaging design, analysis and documentation.
Formulation and Technical Assistant Assist with the formulation, manufacturing and testing of polyacrylamide electrophoresis (PAGE) gels, kits and reagents. Installation, training and support of Lipoprint System including preparation of training materials. Provide technical support on research and development of electrophoresis kits and reagents as needed. Perform verification and validation studies of electrophoresis methods and equipment. Create, review and update documents such as Manufacturing Documents, Material Specifications, Operating Procedures and other documentation according to company requirements.
Skills: Bachelor's degree in Chemistry, Biology or equivalent; or equivalent of two to four years related experience and/or training, or equivalent combination of education and experience. Knowledge of iMac computers. Experience in a cGMP working environment required.
Sr. Quality Assurance Specialist
Functions as a management representative for ISO and FDA. Resolve all conflicts between the quality program and any other policies, procedures or operation within the company and implement the necessary changes. Develop and effectively implement quality system procedures to assure maintenance of GMP Class II Device Compliance, ISO 9001, ISO 13485 and CE Mark Certifications. Review and approve Technical Dossiers for submission to governing bodies. Manage internal and vendor audits according to FDA CFR 820, ISO 13485:2003 and European regulations. Responsible for obtaining and renewing licenses with US, Canada and International agencies. Manage document control activities, nonconformance, corrective and preventative action processes as well as other processes as assigned. Skills: Bachelor's degree in Science or Engineering and minimum of 5 years industry knowledge. Experience in quality assurance and regulatory affairs for IVDD and MDD. In depth knowledge of the FDA Quality System Regulation and ISO 13485:2003 and related regulations and standards. Experience escorting FDA Investigators and ISO notified body auditors
Sr. Manufacturing Engineer, Supply Chain The Sr. Manufacturing Engineer is responsible for providing leadership and insight, as appropriate, into the supplier base toward quality improvement, cost reduction and new product development programs. This position ensures that supplier manufacturing processes deliver consistently high quality products to the company at competitive pricing throughout the product life cycle. Oversees supplier efforts resolving quality problems including performing root cause analysis of nonconforming materials and developing corrective action plans. Works with suppliers to disposition non-conforming product and recommends revisions as required. Lead and facilitate cross functional team in the identification and qualification of new suppliers thorough evaluation of the suppliers manufacturing capabilities in accordance with company policies and procedures. Participates in activities required to establish and maintain supplier rating at appropriate level of approval. Skills: Bachelor's Science Degree in Engineering with 5 years experience in a medium-volume electronics manufacturing environment. Knowledge of CGMP and ISO 9000 requirements are desirable.
QA Manager Responsible for the management and supervision of Quality Assurance activities including Receiving Inspection, In-process Inspection, Final Release, Non-conforming material control and Supplier Control. Responsible for Supplier Management including maintenance of Approved Supplier List, Supplier Files and documentation as required to demonstrate compliance with regulatory requirements. Creating statistical analysis and reports from supplier and nonconforming material databases to identify trends and drive corrective actions. Conducts investigations into nonconformities and supplier issues in accordance with CAPA procedures. Quality Auditor for internal and supplier processes.
Skills: Bachelor's degree and/or equivalent work experience. Five (5) to ten (10) years Quality Assurance experience with emphasis in Quality control, Material Review Board, Documentation Control and Data Center, Internal Audits, Corrective Action, Training, Receiving Inspection, Supplier Quality Assurance. Compliance related to cGMP, ISO13485, and the Medical Device Directive (MDD), or other government related quality systems preferred.
Manufacturing Engineer Support Operations group through development and support of manufacturing equipment and processes in assembly of an implantable medical device. Support production through efficient and effective identification and resolution of line issues. Identify and initiate process improvement projects that have meaningful impact on product quality and process yield. Interface with Design Engineers to provide timely feedback on proposed designs and influence organization to develop a strong design for manufacturability culture. Skills: Bachelor of Science degree in manufacturing, mechanical engineering, or electrical engineering and 3 years of experience in medical or other high-reliability manufacturing environment, or equivalent combination of education and experience. CAD Mechanical design experience developing tooling and fixtures Equipment knowledge and process experience with electromechanical assembly, such as welding, soldering, adhesive bonding, hermetic sealing, surface finishing, packaging, or sterilization. Experience with Statistical Process Control, Design of Experiments, Just in Time, and Lean manufacturing techniques.
Sr. Electrical Engineer
Responsible for the design, development and implementation of battery and electromechanical components and systems to support new medical products in the field of cardiac resuscitation.
Lead the design and development of new battery, power system electronics, and electromechanical systems and components (e.g., motor, motor controller, encoder).
Participate in the strategic planning of new product development, product improvements and enhancements. Work closely with other electrical, software, mechanical, and manufacturing engineers, to define system requirements and architecture. Represent electrical design in cross functional project teams. Define and lead testing, verification and validation of battery and electromechanical systems and components.
Skills: Strong background in battery and power systems, electromechanical design, and analog and digital electronics. Experience in medical device development in a small company or start-up environment. Knowledge of real-time embedded systems. Ability to take a systems view of product development. Self-directed with a demonstrated ability to plan and prioritize work across multiple projects. Knowledge and application of international safety and operating standards for medical devices, e.g. EN 60601, UL2601 and the like. Minimum of 10 years electrical design experience. Minimum BSEE, related degree or equivalent experience – MSEE and advanced degrees desirable.
Sr. Production Test Engineer
Support all operational aspects of electrical test processes used in manufacturing. Develop electrical testing and troubleshooting procedures for hybrid and implantable defibrillator electronics. Document these procedures in accordance with the company’s Quality System. Perform advanced troubleshooting of electrical test failures. Appropriately document all troubleshooting activities and disposition failures in accordance with the company’s Quality System. Perform advanced troubleshooting of electrical test equipment issues. Properly document all maintenance and calibration activities in accordance with the company’s Quality System. Develop and maintain database for logging and tracking electrical test results. Validate database to comply with the company’s Quality System and external standards.
Skills: Bachelor of science degree in electrical engineering, and 3 years of manufacturing test experience in medical or other high-reliability environment, or equivalent combination of education and experience. Experience with both analog and digital circuit design. Strong knowledge of standard electronic troubleshooting processes. Familiarity with electronic equipment such as oscilloscopes, logic analyzers, DVM’s, spectrum analyzers, and computerized test equipment.
Quality Assurance Associate
Support quality assurance and regulatory groups to ensure quality product and compliance with quality system policies and procedures, FDA and international requirements, and ISO Standards for class III Medical Devices. Responsible for the maintenance of the CAPA system. Responsible for the maintenance of the Internal Audit system. Responsible for ensuring CAPA, Internal Audits and Customer Complain data is accurate and collected n a timely manner. Responsible for the reporting and trending of CAPA, Internal Audits and Customer Complaint data. Skills: Bachelors degree, or Associates degree with 2 years related experience (medical device experience preferred), or equivalent. Sound working knowledge of computer software [Microsoft Word, Microsoft Excel] (required) along with various statistical programs [Minitab, SPSS, WinSPC] (preferred).
Principal Test Engineer
The Principal Test Engineer is responsible for creating and implementing test software to test products designed and manufactured at company. The testing will be in support of Engineering Validation and Manufacturing Test Systems. Design, code and debug software as needed for automated or manual test equipment. Lead in the resolution of test system vs product performance anomalies. Develop the documentation associated with the design activities. Lead test equipment hardware/software system architecture design tradeoffs. Develop test equipment requirements and specifications as required. Skills: 4 year college degree in Engineering, Physics, Computer Science or equivalent degree. 7 years minimum of code writing in C# , C++ or C coding languages. 4 years minimum experience in developing automated software and hardware test equipment. Working familiarity with state of the art software methodology and tools. Working knowledge of electronics. Must be able to read electrical schematics
Electrical Engineer
Researches, develops, designs, and tests electrical components, equipment, and systems by performing the following duties System Level Design and PCB design for Electromagnetic Compatibility. Understanding of EMC requirements and test methods for medical products. Design of electronic assemblies for ventilator and related equipment to include general analog, digital, motor control, and micro-processor design. Schematic capture using OrCAD or similar software tools.
Skills: Bachelor's degree or higher degree in engineering or physical science. (Exceptions may be made for especially qualified individuals). Knowledge of standard schematic drawing practices, and PCB design practices. Knowledge of lab electrical equipment (ie oscilloscope, logic, analyzer, etc....) and lab diagnostic techniques. Must have 5+ years of overall experience and direct experience in electrical engineering.
Quality Engineer Manager
Responsible for managing the processes of Supplier Control, Non-conforming Material, and Equipment Calibration and Maintenance. The manager will provide quality engineering support for these processes as well as for Design Control, Change Control, Manufacturing Support, CAPA and Software Validations associated with Quality System software implementations. Manage the process of Supplier Control and Non-conforming Material. Responsible for Equipment Calibration and Maintenance processes. Provide Quality Engineering support for Design Control, Change Control, Manufacturing Support, CAPA and Software Validations. Interprets drawings and specifications to determine characteristics to be inspected for receiving, in process, final inspections and first article inspections. Skills: Bachelor's degree in Engineering (Mechanical or Software). Requiring Five (5) plus years experience in the medical device industry with Class II or III devices. Management experience is desirable. Knowledge of process monitoring and controls. Experience as an auditor against ISO13485 requirements, understanding the US Quality System Requirements for Medical Devices.
Regulatory Affairs Manager
The Regulatory Manager will be responsible for managing the regulatory submissions associated with new and revised designs. Submissions include US 510(k)s, Technical Files for CE marking, Canadian Medical Device Registrations files, and Australian TGA submissions. Work with Japan affiliates on submissions in accordance with the Japan PAL. Responsible for device tracking orders and post market requirements as required for product approvals. Skills: Applicable Bachelor's degree or equivalent preferred (biological or engineering major )or comprehensive working knowledge and at least three (3) years of medical device experience with Class II or Class III devices and submissions. Must have successful track record with submissions written recently. Must have an understanding of US Quality Systems Requirements for Medical Devices and CE marking requirements for EU. Understanding of Canadian, Australian and Japan Medical Device regulations desired. Must have knowledge of Microsoft office, Visio and Project desired.
Inspector, Quality Control
Provide incoming, in-process, and final inspection/testing. Duties include first article inspections, identifying non-conformances, and documentation review. Support manufacturing schedule by providing inspections of incoming materials, in-process materials and finished devices as assigned for electromechanical as well as sterile disposable products. Complete First Article Inspections including supporting documentation. Identify and record any product quality problem(s). Review of device history records, and perform product release. Support inspection of engineering prototypes. Document Control experience a plus. Data entry experience a plus.
Skills: Experience in a medical device, FDA QSR regulated industry, including ISO 13485 requirements. Experience inspecting sterile disposable catheters, electro-mechanical assemblies, as well as printed material and labeling. IPC 610 ore equivalent experience. Be able to interpret the sampling plans (e.g., ANSI Z1.4, C =0). Experience using Excel, Word, Access. High School or equivalent, or equivalent industry experience. Minimum of 3 years related experience in medical device industry.
Electrical Engineer
Develop analog and digital electronics for a new series of medical instruments and devices. Responsibilities will cover a wide range of hardware development. Define overall product requirements and hardware specifications. Work closely with software and mechanical engineers to define system requirements. Design, test and document electronic products. Help to select microprocessors, system architecture. Evolve early feasibility designs into commercial products.
Skills: Strong background in analog and digital design. Embedded system design. Microprocessors: Motorola 68000 or HCXX, Intel 80X86 or 80X51 families, or similar devices. System Architecture: Familiar with memory options, AD, power supplies, and electromagnetic interference. Minimum BSEE or related degree or equivalent experience - MSEE and advanced degrees desirable. Minimum of 0-3 years related experience. Analog Circuits: Experience with Signal Conditioning, Active Filters, Electrical Isolation.
Sr. Manufacturing Engineer
Responsible for developing, implementing, and validating processes and procedures to manufacture electromechanical and catheter-based medical devices in full compliance with the company’s quality system. Apply Lean Six-Sigma concepts to reduce waste and maximize efficiency. Troubleshoot production issues. Work with vendors to drive cost reductions to existing components and assemblies. Works closely with R&D engineers during the product design phase to ensure Design for Manufacturability requirements are considered and implemented. Understands the product design to implement and improve manufacturing processes. Develops and improves existing manufacturing methods, fixtures and assembly aids. Analyzes and documents workflow. Works with production to layout equipment and workspace for maximum efficiency. Troubleshoots production issues and implements appropriate solutions. Uses DOE techniques to characterize and improve processes and production yields. Creates verification and validation test protocols and reports including equipment IQ/OQ/PQ as required. Skills: Solid background in electrical, mechanical, and/or materials engineering. Able to use Solid Works or Pro-E to document fixtures and assembly aids. Preferred B.S. in Electrical Engineering. Minimum 5 years manufacturing engineering experience, preferably in a regulated environment . Experience with Design for Manufacturing (DFM), Design of Experiments (DOE) and product/process Failure Mode and Effects Analysis (FMEA). Medical device manufacturing involving electromechanical and/or catheter-based products.
DIRECTORS & MANAGEMENT
