Product Life Cycle Engineer
Burlington, MA
Experience: 0
Category: Engineering
Brand: Joule
Job ID: 294676
Date Posted: 03/13/2023
Shortcut: http://jobs.systemoneservices.com/vjvvgO
Product Life Cycle Engineer
Location: Burlington, MA. area
Start Date: ASAP!
Duration: Direct Hire
Hours: Mon-Fri; 8am-4:30pm
Degree/Experience/"Must Haves":
- Minimum of a BS degree in a technical field
- Minimum of 4 yrs. of relevant work experience ideally in Med Device
- Minimum of 3 yrs. product development experience with a proven track record of accomplishment: direct association with or leading efforts to develop technically sophisticated products from concept to market
"Must Haves":
- Detailed knowledge of new product development processes and/or change management methodologies in a medical device or IVD setting
- Working knowledge of ISO13485; ISO14971 and FDA GMP/QSR
- Consistent track record to deliver project outcomes in an ambiguous environment
- Experience leading self-directed work teams
Duties/Responsibilities:
- Develop strong partnerships with multi-functional leaders to ensure that alignment, efficiency, and execution meet business requirements
- Ensure that the voice of the customer is present in all decisions and that all design requirements are translated into practical design changes that can be verified and ultimately validated in manufacturing
- Ensure projects are carried out in compliance with regulatory requirements (GMP, ISO, MDD/MDR) and company policy & procedure requirements
- Continuously engage with Regulatory affairs and Quality affairs teams to ensure that all standards are current and fully applied to our products.
- Conduct Gap assessments on product technical documentation and make recommendations for improvement.
- Initiate change orders for implementation of changes or guide cross-functional groups to do the same.
- Participate in CAPA process as it relates to product conformance
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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