Mechanical Engineer — Medical Device (Onsite — Arden Hills, MN) Contract with Possible Extension

Job Description

Our   F500 Medical Device   client has an exciting opportunity for a   Mechanical Engineer.

Job 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 twelve 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.

Responsibilities :

Identifying   gaps in the   acquired   company’s test method validation compliance to   the 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 novel assignments   requires   the development of new or improved techniques and procedures.   Work   is expected to result in efficient and effective integration of medical device technologies   into   the   client’s   portfolio.

Completing engineering work in one or more of the following :   t echnology 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.

Successfully completed clear and concise engineering documentation.

Demonstrating Technology Development and Product Development system knowledge through delivery of high quality, high impact deliverables.

Job Requirements :

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 bachelor’s degree, or 2+ yrs with 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.

10% travel

Must work onsite 3 days per week minimum at our Arden Hills, MN location

Preferred Qualifications :

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

Other Details :

Schedule :   06 : 00 : AM - 02 : 30 : PM

Contract Length :   12 months with   possible extension

Work Set-Up :   Onsite 3 days per week minimum in Arden Hills, MN

Start Date :   12 / 1 / 2025

Travel Requirements :   10 %

Requirements

Responsibilities : Identifying gaps in the acquired company’s test method validation compliance to the 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 novel assignments requires 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 delivery of high quality, high impact deliverables. Job Requirements : 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 bachelor’s degree, or 2+ yrs with 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. 10% travel Must work onsite 3 days per week minimum at our Arden Hills, MN location Preferred Qualifications : 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 Other Details : Schedule : 06 : 00 : AM - 02 : 30 : PM Contract Length : 12 months with possible extension Work Set-Up : Onsite 3 days per week minimum in Arden Hills, MN Start Date : 12 / 1 / 2025 Travel Requirements : 10%