Mechanical Engineer II

Job Title : Mechanical or R&D Engineer

Location : Minnesota (Onsite)

Position Overview :

We are seeking a highly motivated Mechanical or R&D Engineer to join our team onsite in Minnesota. This role will be instrumental in evaluating and validating test methods used in medical device design and development, with a strong focus on ensuring compliance with industry standards and internal procedures.

You will play a key role in assessing test methods from an acquired company, identifying validation gaps, and implementing testing strategies or documentation updates as required. This is an exciting opportunity to contribute to the successful integration of medical device technologies in a regulated environment.

Key Responsibilities :

Evaluate and validate existing test methods for compliance using Gauge R&R and other statistical techniques.

Assess acquired test methods to determine the need for additional validation testing or documentation justification.

Collaborate with subject matter experts to provide testing solutions and technical support.

Identify and close gaps in test method validation compliance with internal Work Instructions and Standard Operating Procedures (SOPs) .

Provide input to project objectives, timelines, and deliverables, and recommend necessary revisions.

Clearly communicate technical risks, progress, and trade-offs to project leadership.

Develop and implement new or improved testing techniques and procedures for novel or complex engineering assignments.