Product Development Engineer
Roles & Responsibilities
- Lead R&D deliverables throughout the medical device design control process.
- Collaborate with a cross-functional team to plan, develop, modify, implement, and support IPD products.
- Develop technical plans, guide design inputs, conduct feasibility studies, refine product designs, verify and validate subsystems and systems.
- Transfer designs to Manufacturing and Operations and support global Regulatory filing strategies.
- Execute design verification testing to confirm design outputs meet requirements.
- Demonstrate knowledge of packaging product design, development, and control processes.
Experience Required
- 5 years of work experience or 3 years plus an advanced degree in ISO 11607, ASTM Packaging Standards, and Medical Device Packaging Design.
- Experience with medical device design control processes and maintaining design documentation.
Skills & Certifications
- Proficiency in SolidWorks or equivalent CAD tools.
- Strong critical thinking and project management skills.
- Ability to manage multiple projects simultaneously.
- Capability to work effectively in cross-functional teams.
- Knowledge of DFSS principles and/or Six Sigma tools (Kaizen, process improvement).
Eligibilities & qualifications
- BS in Mechanical Engineering, Materials Engineering, or Biomedical Engineering.
- Strong communication skills, both verbal and written.
- Demonstrated ability to work effectively within a cross-functional team.
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