Description: Hybrid - 3 days on-site, Weaver Lake or Arden Hills.
About the Role
The Urology Research & Development (R&D) organization is seeking two highly skilled and motivated contract engineers to support the Valencia Technologies integration project through February 2027. In this role, you will support the integration of the acquired company's Design History File (DHF) to *** compliance, with primary emphasis on design outputs, design verification prerequisite deliverables and execution, test method development and validation, technical problem-solving and issue resolution, and DHF documentation.
As a key team member, you will provide technical solutions and support under some guidance from our subject matter experts. You will utilize your background in mechanical and/or systems design, design verification, test method development and validation, verification testing, engineering documentation, and technical problem-solving.
Responsibilities include:
"Successfully completing engineering work in one or more of the following: design outputs; design verification prerequisite deliverables and execution; Design Verification test method development and validation; Essential Design Output identification; System/Subsystem/Component requirements tracing; and Design FMEA
"Providing input to project goals and progress and recommending appropriate revisions.
"Communicating progress, risks, and trade-offs of technical deliverables to R&D technical leadership and recommending revisions as needed.
"Completing complex rationale on ability or inability to leverage acquired company documentation. Work is expected to result in efficient and effective integration of medical device technologies to the *** portfolio.
"Providing technical problem-solving and issue resolution, including assessing the feasibility and soundness of alternative engineering processes, products, equipment, or documentation approaches.
"Completing clear and concise DHF and engineering documentation, including protocols, reports, rationales, design outputs, and verification-related deliverables.
"Demonstrating Technology Development and Product Development system knowledge through delivery of high quality, high impact deliverables.
Required Qualifications:
"BS or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field
"4+ yrs of Medical Device 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
Preferred Qualifications
"Familiarity with IEC 14708 and 45502 Active Implantable standards
"Familiarity with IEC 60601 Medical Electrical Equipment standards
"Experience with statistical techniques (Gauge R&R, Process Capabilities Studies) and Minitab
"Experience in requirements tracing applications like Cognition Cockpit
"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