Product Engineer

5 days ago

Traverse City, Michigan, United States Thompson Surgical Instruments Full time

Thompson Surgical Instruments has an opportunity for a Product Engineer.

The Product Engineer is a member of a dynamic team that provides technical leadership and collaboration with a mix of Design Engineers, Product Managers, Verification Engineers, and Risk Engineers while working with an interdisciplinary team including Marketing, Regulatory, and Quality. This individual will work on new projects from concept to commercialization and projects that maintain our currently released products/system. The individual will be responsible for defining, analyzing and implementing system and part requirements to ensure our products meet user needs, can be validated, conform to usability standards as well as provide input to cross-functional deliverables. Some travel required.

We're an energetic company and looking for a passionate individual to join our organization and enhance our team. Thompson is employee-owned, and vested employees automatically receive company shares.

What You'll Do:

  • Provide technical leadership on a cross-functional development team.
  • Define and analyze system requirements, clinical workflows, and input/output processes by using current engineering methods and technologies.
  • Solve system problems by analyzing the situation and recommending corrective or alternative actions.
  • Document system-level design control elements by writing documents, reports, and memos.
  • Provide expertise and conduct evaluation of validation and usability activities.
  • Collaborate with Verification Engineers to determine if design inputs can be verified or validated (or both) in accordance to ISO 13485.
  • Collaborate with Risk Management to ensure the Use Case hazards are identified and mitigated in our Risk Management Process (ISO 14971)
  • Direct and assist with industry-based standards for Usability (ISO
  • Work with a cross-functional team and serve as an R&D representative on cross-functional deliverables.
  • Collaborate on all UFMEA and DFMEA activities for all products/projects.
  • Using CAD software, review product designs and features to meet product and marketing specifications.
  • Communicate with engineers and product managers to gain knowledge of product design requirements.
  • Work within project plans to execute assigned projects.

This Might Describe You:

  • Engineering degree (Mechanical, Biomedical) or Biological or Physical Sciences degree and experience driving projects and tasks to closure.
  • Medical Device design experience preferred.
  • Clinical experience preferred.
  • Usability engineering experience preferred
  • Strong communications and time management abilities.
  • Ability to provide technical leadership within cross-functional teams.
  • Track record of independent and solution-oriented work style.

EEO/AA

Job Type: Full-time

Benefits:

  • 401(k)
  • Dental insurance
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Parental leave
  • Retirement plan
  • Vision insurance

Work Location: In person

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