Senior PLM Engineer

About This Role

The Senior PLM Engineer will support existing products and engineering activities for product acquisitions within a medical device company. This role involves managing design, material, specification, and packaging changes.

Responsibilities

• Responsible for product design ownership for commercialized products
• Work closely with supply chain, manufacturing engineering, quality, and regulatory to assess and implement changes
• Responsible for product engineering in compliance with medical device Design control requirements globally
• Project management for engineering changes or projects requiring a small project team
• Serve as the primary R&D resource assigned to product design change projects

Requirements

• Minimum 8 years of experience (6 years with a master's degree) in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Science & Engineering, or closely related field
• Experience with statistics and design of experiments
• Project management experience and 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

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Science & Engineering, or a closely related field
• Minimum 8 years of experience with a bachelor’s degree (6 years with a master’s degree)

Nice to Have

• Experience working in a highly regulated industry (medical device or pharmaceutical)
• 3D CAD software skills (Solidworks)
• Lean / Six Sigma training certifications

Skills

* Required skills

Benefits