Senior Sustaining Engineer

Stryker Employment Company • Bloomington, MN

214d • Remote

About The Position

The Senior Sustaining Engineer will be responsible for the technical support and maintenance of the product and documents after its release, ensuring its continued operation and addressing any issues that arise throughout its lifecycle. Provide engineering expertise to cross-functional project teams. Support a portfolio of small to intermediate size sustaining engineering projects. Potentially lead smaller projects. Sustaining projects and activities typically originate from the following areas, and include: Manufacturing support: Resolve supply chain issues. Support product transfers, audits, NC/CAPAs, item master updates, BOM updates, and change assessments. Supplier activities: Lead or support supplier changes to processes, design and/or materials. Resolve supplier issues. Execute assigned projects and activities to agreed timelines. Create, review, and update manufacturing procedures Create, review, and update production level drawings for components and assemblies. Perform process verification/validation. Develop strong product knowledge to provide technical expertise to other functional areas. Perform gap analyses of existing design files due to new or changing regulations (i.e. EUMDR) and keep product documentation updated per MDR. Improve processes, always looking for more efficient and effective ways of achieving results Support the AO design transfer agreement plan (DTAP) review.

Requirements

• Bachelor's degree in manufacturing, industrial, or mechanical engineering.
• Two (2) plus years' experience in a Manufacturing setting.

Nice To Haves

• Proficiency in Microsoft Office.
• Good knowledge of general engineering principles.
• Solid knowledge of regulations for medical device development, including ISO 13485 and FDA standards.
• Excellent written and verbal communication skills.
• Extensive understanding of processes used in the design and manufacturing of medical devices.

Responsibilities

• Provide technical support and maintenance of the product and documents after release.
• Ensure continued operation and address issues throughout the product lifecycle.
• Provide engineering expertise to cross-functional project teams.
• Support a portfolio of small to intermediate size sustaining engineering projects.
• Lead smaller projects as needed.
• Resolve supply chain issues in manufacturing support.
• Support product transfers, audits, NC/CAPAs, item master updates, BOM updates, and change assessments.
• Lead or support supplier changes to processes, design, and/or materials.
• Resolve supplier issues.
• Execute assigned projects and activities to agreed timelines.
• Create, review, and update manufacturing procedures.
• Create, review, and update production level drawings for components and assemblies.
• Perform process verification/validation.
• Develop strong product knowledge to provide technical expertise to other functional areas.
• Perform gap analyses of existing design files due to new or changing regulations.
• Keep product documentation updated per MDR.
• Improve processes for more efficient and effective results.
• Support the AO design transfer agreement plan (DTAP) review.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree