Job Description

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
  %