Product Development Engineer
SkyWater is partnering with a growing medical device manufacturer in Upstate New York to hire a Product Development Engineer for their engineering team! Our client recently received FDA approval for a key product line and is entering an exciting growth phase, scaling from small-batch manufacturing into a commercialized business with an expanding product pipeline. This is a great opportunity to help build and shape a product development function almost from the ground up, working on new IP and next-generation product design. We’re looking for a hands-on Engineer with 3-5 years of medical device (or similar regulated industry experience) product development experience, and strong SolidWorks skills. If you’re looking for an opportunity to join an innovative, growing organization where your work can make a big impact, then please submit your resume today to be considered for this exciting opportunity!
Responsibilities
- Lead technical aspects of new product development and re-design of existing medical devices, from research & design planning through verification & validation.
- Perform tolerance analysis, material selection, and design for manufacturability (DFM).
- Generate and maintain design documentation, including requirements, risk analyses, drawings, specifications, and design history files (DHF).
- Participate in risk management activities, including hazard analysis, FMEA, and risk mitigation.
- Collaborate with Manufacturing Engineering to transfer designs into production and support change management documentation.
- Support supplier development and qualification projects as needed and collaborate with Regulatory Affairs team members on product submissions.
- Investigate and resolve design-related nonconformances, complaints, and CAPAs.
- Identify opportunities to improve product performance, reliability, and cost.
Desired Skills and Experience
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
- 3-5 years of product development engineering, mechanical engineering, or similar engineering experience.
- Experience working in the medical device industry or a similar regulated industry.
- Proficient working in SolidWorks (CAD) or similar design software.
- Strong written and verbal communication skills.
Submit Your Resume
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