Mechanical Engineer

Mechanical Engineer

Required

Skills & Experience:

• BS or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field

• 4+ yrs of engineering or related experience with Bachelor's Degree, or 2+ yrs with Master's Degree

• Strong mechanical and/or systems engineering and problem-solving skills and attention to detail

• Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources

• Strong written and verbal communication, judgment, decision-making, collaboration, and critical thinking skills

• Personal drive, individual accountability & a strong bias for action.

• Must work onsite 3 days per week minimum at our Maple Grove, MN location

Nice to Have

Skills & Experience:

• Familiarity with IEC 14708 and 45502 Active Implantable standards

• Familiarity with IEC 60601 Medical Electrical Equipment standards, including laser-specific sections

• Experience with statistical techniques (Gauge R&R, Process Capabilities Studies) and Minitab

• Experience in single-use device or active implantable test methods and test method validation

• Ability to build strong relationships across the organization and with external stakeholders

Job Description:

We are seeking a highly skilled and motivated Mechanical Engineer to join our acquisition and integration project for a duration of 12 months, with the high likelihood of contract extension. In this role, you will provide support in validating existing test methods to our client's compliance standards using Gauge R&R or other methods. This role would be responsible for assessing the acquired company's design test methods to determine if validation testing is required and either running the appropriate tests or updating associated documentation to rationalize why no testing is required.

As a key team member, you will provide testing solutions and technical support under some guidance from our subject matter experts. You will utilize your background in mechanical and/or systems design, test method design and validation, verification testing and statistical analysis.

Your responsibilities include:

• Identifying gaps in the acquired company's test method and test method validation compliance to our client's Work Instructions and SOPs and defining strategy to close these gaps.
• Providing input to project goals and progress and recommending appropriate revisions.
• Communicating progress, risks, and trade-offs of technical deliverables to project leadership, and recommends revisions as needed.
• Development of mechanical test methods utilizing MTS Systems
• Coordinating with external test houses for test execution
• Design test method validations (TMV's) and management of TMV execution
• Create TMV reports
• Completing clear and concise engineering documentation.