Job Title: Product Development Engineer
About the Role
This is an exciting opportunity to join our team as a Product Development Engineer. As a key member of our Patient Specific Solutions team, you will be responsible for designing and developing innovative patient-specific devices. Your primary focus will be on creating high-quality implant and instrument designs that meet the needs of our customers.
Key Responsibilities
- Design and develop patient-specific implants and instruments, ensuring they meet critical design prerequisites, including patient and customer safety, mechanical, and biological suitability.
- Work closely with customers, including surgeons, OR staff, clinical staff, distributors, and sales teams, to provide design solutions that meet their needs.
- Collaborate with cross-functional teams, including Design Coordinators, Manufacturing Team Leaders, Product Engineers, Inspectors, Customer Services, QA/RA personnel, and subcontractors, to ensure efficient manufacturing and progress of each case.
- Ensure standard templates used for design are current and updated in a timely manner.
- Conduct risk assessments and document activities and justifications/validations to satisfy regulatory requirements under the guidance of Quality and Regulatory Affairs counterparts.
Requirements
- Bachelor's degree in a science or engineering discipline, with Mechanical or Biomedical Engineering being preferred.
- 0-2 years of product design experience in the medical device industry or equivalent.
- Fundamental understanding of design controls and risk management within a regulated industry, preferred.
- Familiarity with parametric CAD design packages, such as Pro/Engineer.
- Ability to communicate effectively through written and oral means.
- Strong analytical and problem-solving skills, with the ability to work independently and as part of a team.
Benefits
We offer a dynamic and supportive work environment, opportunities for professional growth and development, and a competitive salary and benefits package.
Other Opportunities
This role offers the chance to make a real difference in people's lives by contributing to the development of innovative medical devices. If you are a motivated and detail-oriented individual with a passion for product development, we encourage you to apply.