Product Development Engineer

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R & D Regular Full-Time Professional Scanlan International, Inc., St. Paul, MN, US

Salary Range: $68,200.00 To $ Annually

Scanlan International, Inc., is a medical device company specializing in the highest-quality surgical instruments. Now in our fourth generation, the Scanlan family continues its dedication to providing the best surgical instrumentation available anywhere in the world. We are seeking a Product Development Engineer I to join our organization and continue this commitment.

The Product Development Engineer I contributes to the design, testing, and lifecycle support of Class I and Class II medical devices, including reusable surgical instruments and single-use products. Working with experienced engineers and cross-functional partners, this engineer completes defined assignments, documents results, follows established development and quality processes, and builds increasing independence through training and experience.

This position is located at our headquarters office, south of downtown St. Paul. We welcome an on-site work environment from Monday to Friday. This position reports to the Director of Research and Development.

• Complete assigned product-development and lifecycle activities using established procedures; track commitments and raise questions, risks, or delays to the project lead.
• Prepare and update assigned product-development records using approved templates; check documentation for completeness and consistency and incorporate reviewer feedback.
• Enter and maintain assigned requirements and traceability using Scanlan’s requirements-management tools and processes.
• Prepare assigned requirements and design-control records for formal design reviews, complete assigned actions, and raise evidence gaps or approval concerns to the project lead.
• Draft and revise procedures, specifications, test methods, protocols, reports, and change assessments using approved templates and incorporate reviewer feedback.

• With guidance, prepare test plans, protocols, acceptance criteria, and reports; conduct approved testing, analyze results, document evidence, and report deviations.
• Support external testing and validation with laboratories, suppliers, design partners, and subject-matter experts; organize required information, review results with the project team, and document deviations or evidence gaps.

• Support new-product and product-improvement concepts by gathering stakeholder needs, completing assigned feasibility work, and summarizing findings for the project team.
• Support assigned design-transfer and product-lifecycle activities with cross-functional teams, customers, suppliers, and external resources; complete readiness tasks and document implementation of approved decisions.
• Participate in Design-to-Cost and Design-for-Manufacturability reviews and update assigned requirements, risk records, verification plans, and design-control documentation to reflect approved decisions.
• Help define product and process characteristics that affect quality and ensure approved requirements are reflected in applicable specifications and inspection records.

• Support risk-management activities by identifying potential hazards, documenting risks and controls, and helping confirm that risk controls are effective.
• Participate in formal design reviews and change-control activities, complete assigned actions,…