Senior PLM Engineer
About The Position
Responsible for product design ownership for commercialized products. Work closely with supply chain, manufacturing engineering, quality, and regulatory to assess and implement changes that impact the product design. Responsible for product engineering in compliance with the medical device Design control requirements globally Project management for engineering changes or projects where a small project team is required to achieve project goals. Will be the primary R&D resource assigned to product design change projects, whether they are being initiated due to design, manufacturing, or other reasons. The engineer will be assigned products in line with the employees’ capabilities.
Requirements
- Typically requires minimum 8 years of experience and a bachelor’s degree (6 years with a master’s degree) in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Science & Engineering, or a closely related field. An advanced degree is preferred.
- Experience with statistics and design of experiments, project management, and the ability to coordinate cross-functional teams and deliverables.
- Basic knowledge of business finance and budgeting. Knowledge of applicable standards/regulations such as GMP, EU MDD/EU MDR, 21 CFR 820 and ISO 13485
- Technical aptitude, "hands-on" approach to engineering, and good understanding of engineering concepts.
Nice To Haves
- Experience working in a highly regulated industry, such as medical device or pharmaceutical, is strongly preferred.
- 3D CAD software skills (Solidworks) preferred.
- Lean / Six Sigma training certifications are a plus.
Responsibilities
- product design ownership for commercialized products
- Work closely with supply chain, manufacturing engineering, quality, and regulatory to assess and implement changes that impact the product design.
- product engineering in compliance with the medical device Design control requirements globally
- Project management for engineering changes or projects where a small project team is required to achieve project goals.
- primary R&D resource assigned to product design change projects, whether they are being initiated due to design, manufacturing, or other reasons
Benefits
- Paid time off and paid volunteer time
- Medical, Dental, Vision and Flexible Spending Account
- Health Savings Account with Company Funded Contributions
- 401k Retirement Plan with Company Match
- Parental Leave and Adoption Services
- Health and Wellness Programs and Events
- Awarded 2024 Cigna Healthy Workforce Designation Gold Level
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What This Job Offers
Job Type
Full-time
Career Level
Senior
