Job Description

Are you an experienced Project Manager with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Project Manager to work at their company in Arden Hills, MN.

Position Summary: The Urology Research & Development (R&D) organization is seeking a highly skilled and motivated Mechanical Engineer to join our acquisition and integration project for a duration of six months, with the option to extend. In this role, you will provide support in validating existing test methods to the client's compliance 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.

Primary Responsibilities/Accountabilities:

• Identifying gaps in the acquired company's test method validation compliance to 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.
• Completing complex or Client assignments requiring the development of new or improved techniques and procedures. Work is expected to result in efficient and effective integration of medical device technologies to the client's portfolio.
• Successfully completing engineering work in one or more of the following: technology development or remediation, product design refinement, test of materials, preparation of specifications, process study, and report preparation.
• Assessing the feasibility and soundness of alternative engineering processes, products, or equipment.
• Completing clear and concise engineering documentation.
• Demonstrating Technology Development and Product Development system knowledge through the delivery of high-quality, high impact deliverables.

Qualifications:

• Windchill and Test Method Validation experience required
• BS or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field
• 4+ yrs of engineering or related experience with a bachelor's degree, or 2+ yrs with a Master's
• 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.

Preferred:

• 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

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