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Job Description

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 12 months, with the option to extend. In this role, you will provide support in validating existing test methods to company 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.

Your responsibilities include:

Identifying gaps in the acquired company’s test method validation compliance to Boston Scientific 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 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 Boston Scientific 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.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and 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. 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