As a member of our Sustaining Engineering team, the Mechanical Engineer will investigate quality issues with distributed products and develop solutions to field issues that ensure the quality and reliability of Nonin Medical products. This position will evaluate mechanical design for necessary design upgrades for end-of-life components and sub-assemblies, and lead and/or support implementation of design changes. Assignments are broad in nature, usually requiring initiative, originality, ingenuity and excellent problem-solving skills.
Essential Job Functions:
- Serve as team mechanical engineer, multitasking among several self-driven projects and cross-functional efforts.
- Evaluate product non-conformances and recommend and implement design modifications.
- Ability to work on complex issues requiring an in-depth analysis of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
- Interact with global and internal design, quality and manufacturing resources to design for manufacturability and test, reliability and cost-effectiveness.
- Review product documentation for accuracy including documentation intended for customer use.
- Analyze and provide feedback on peer designs in an open and collaborative design review forum.
- Actively participate on cross-disciplinary teams to address design issues or maintenance of existing products.
- Record and share technical knowledge gained with colleagues.
- Evaluate, test, and review revised designs to determine if product will perform according to requirements and specifications.
- Maintain accurate records throughout all processes in order to comply with company and government standards and/or regulations.
Required Education & Experience:
- Bachelor’s degree in Mechanical Engineering or Biomedical Engineering with a focus on mechanical design, from an ABET-accredited university or college.
- 2+ years of experience in mechanical design and manufacturing.
Required Knowledge, Skills and Abilities:
- Experience working in cross-disciplinary teams.
- Experience with Pro-E and AutoCAD.
- Experience with plastic injection molding including insert molding and over-molding.
- Desire to drive accountability across project teams and functional team members.
- Two years of experience in medical device mechanical design and manufacturing.
- Experience with selection of materials for medical devices based upon biocompatibility and durability requirements and materials interface requirements.
- Experience with Medical Device Directive (MDD), ISO 13485, FDA QSR and design controls or similar regulatory environment.
- SolidWorks experience.
- Experience with PDM (Product Data Management) and PLM (Product Lifecycle Management).
- Sit, and/or stand for 8 hours per day
- Examine assemblies and subassemblies using a microscope and other tools.
- Occasionally lift and/or move up to 50 pounds.
- On call or after hours support – may be required to support process and design validation efforts during weekends or after work hours.
Nonin Medical is an Equal Opportunity/Affirmative Action Employer - Minority/Female/Disabled/Veteran.