Quality Engineer II - Medical Device Development
About Plexus Engineering Solutions
Plexus engineers serve as the product design and engineering engine for leading companies, across major industries.
Through our diverse range of product and technology solutions Plexus engineers impact lives throughout the globe. We deliver innovative solutions throughout the entire product lifecycle, from early concept development to manufacturing and beyond.
Supporting a large breadth and variety of products, Plexus engineers work in a fast-paced, high variety, technically challenging environment that provides intense technical and leadership development. Passionate about customers, our teams have an industry-leading record of technical achievement.
At Plexus, you will maximize the impact of your engineering and leadership talent.
About The Boulder Design Center
With a local population that boasts more Ph.D.'s per capita than any other US city, the Boulder Design Center's 70 engineers and designers serve customers in the Western and South-Western United States. Our engineers form a close-knit, elite team with 16 years of history providing leading companies high quality, innovative designs. Situated at the gateway to the Rocky Mountains, Boulder is a family friendly city with a small town feel, consistently ranked as one of the best places to live in the United States. Featuring a lively arts and culture scene, prestigious universities, Boulder is only miles from world class skiing, trails, and gorgeous mountain scenery.
About the Role
The Quality Engineer for Medical Device Development will serve as the focal point for the project team and the customer on topics related to safety agency and regulatory compliance as well as the necessary quality system(s). The Quality Engineer has overall responsibility for assuring that the product is designed and tested in compliance with applicable domestic and international regulatory agencies and/or bodies. This includes but is not limited to: participating in the development of the product specifications, defining project compliance to internal and external standards, coordinating safety agency marking and regulatory compliance, coordinating the risk management and human factors activities, and coordinating design verification test activities.
* Ensure that the planned project activities are compliant with Plexus' standard operating procedures and ISO (i.e. 13485) quality systems, the FDA Quality System Regulation (QSR) regulations.
* Understand Design History File (DHF) content requirements and be capable of performing all aspects of DHF maintenance.
* Support proposal activities for new business and other marketing support as requested.
* Participate in the Plexus quality system development and maintenance.
* Understand medical device safety standards (i.e. IEC 60601-1), regulatory requirements, and be capable of identifying those that are applicable for each unique product.
* Determine appropriate specifications to comply with regulatory and compliance requirements of intended markets.
* Mentor and lead the project team on regulatory and safety agency compliance requirements of intended markets.
* Facilitate documentation of functional, electrical and mechanical specifications.
* Lead the development of the product Risk Management Plan and maintain customer specified content of the Risk Management File for each unique product.
* Lead product Risk Analysis meetings and document the results as specified in ISO 14971. Follow up as required throughout the project to ensure adherence to risk management plan. Risk activities also include coordination of Design Failure Modes and Effect Analysis reports, Fault Tree Analysis, and other risk reports.
* Coordinate device reviews with safety agencies.
* Coordinate all Design Verification Test activities, including generation of the verification Plan, Procedures and Report documents.
* Review design related project documents and drawings to ensure internal and external requirements are met.
* Participate in engineering reviews to ensure they are conducted and documented as appropriate.
Skills & Abilities
* Possess a strong working knowledge of medical device and similar safety standards (i.e. IEC 60601-1, IEC 61010-1)
* Possess understanding of regulatory requirements such as FDA Quality System Regulations, ISO 13485 and the EU Medical Device and In Vitro Diagnostic Medical Device Directives
* Experience with the development of risk management planning and analyses as defined in ISO 14971
* Experience with Design Verification Test activities including test planning, test procedure and test report development
* Experience working with safety agency test labs for agency certifications such as UL, CSA, CE, etc.
* Possess at least basic knowledge of the Software Quality Engineering functions
* Possess excellent verbal and written communication skills as well as interpersonal skills necessary to work across multiple engineering disciplines, project management, and external customers.
* Must be able to work in a matrix style organization on multiple projects simultaneously.
Education & Experience
* A Bachelor's degree in a scientific, engineering or equivalent background is required for this position
* Experience of 4 years in medical device product development or equivalent industry experience is required for this position
All offers of employment are contingent upon successfully passing a drug screen and upon completion of a confidentiality agreement.
Our Values and How We Lead behaviors guide our processes. Plexus does not make employment decisions based on race, color, religion, national origin, sexual orientation, gender identity, disability, or veteran status. We are proud to be an Equal Opportunity Employer (EOE) and encourage all to apply today!
Globally, our policy is to recruit people from wide and diverse backgrounds. However, certain positions require access to controlled goods and technologies subject to the International Traffic in Arms Regulations (ITAR) or Export Administration Regulations (EAR). Applicants for these positions may need to be U.S. Persons, which is generally defined as a U.S. citizen, permanent resident (green card holder), or individual granted political asylum.
Working At Plexus
Empowering People, Innovating Solutions, Achieving Excellence
Plexus is a global company that values your growth and development and knows that our success is the direct result of our empowered, hard-working and dedicated people. At Plexus you can push the boundaries of innovation and discover your highest potential. Whether you're an experienced professional or skilled manufacturer looking to expand and enhance your career, a recent graduate ready to make an impact or a student eager to gain hands on internship experience, you can make a difference with us.
At Plexus we provide opportunities for growth and development at every level and encourage all employees to be leaders. The foundation of our culture is built around Our Values and How We Lead behaviors exemplified by our Plexus People: Customer Focus, Relationships & Teamwork, Integrity, Open Communication, Excellence, Prioritize Our People, Solve Problems, Be Courageous, Be Strategic, and Innovate.
Our global operations allow us to attract people with broad and diverse backgrounds from all over the world. Discover why more than 12,500 dedicated individuals choose Plexus as the workplace of choice to grow their careers. Apply today!