Director Biomedical Engineer Jobs in Colorado (NOW HIRING)

Position Description:

Direct a team including Mechanical, Hardware, Electrical, Electronics engineers, and their activities to attain business goals consistent with cost, high quality, reliability, and delivery requirements. Coordinate with departments including Supply Chain, R&D, Commercial, Quality and Regulatory to improve existing processes for new and mature products. Leverage global offshore teams, providing technical guidance, mentorship, and professional development opportunities in support of launching electro-mechanical products, through streamlined collaboration and process optimization. Responsible for the development of electronic-mechacia systems and components as well as the design and development of capital medical devices. Navigate the complexities of various government and industry regulatory standards including FDA Quality Systems Requirements (QSR), ISO 13485, ISO 9001, ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, and IEC 60601-2-2. Manage electrical safety and electromagnetic compatibility (EMC) / electrostatic discharge (ESD) testing, implement robust design techniques, to reduce field failures and improve product reliability. Utilize digital and analog hardware design to include custom digital, analog, and power electronics circuit design, off-the shelf equipment with high-voltage and high-current power systems. Navigate Basic input/output system (BIOS), Unified Extensible Firmware Interface (UEFI), Quantum's Network eXecutive (QNX), and Linux operating systems on single board computers, Field-Programmable Gate Array (FPGAs) and embedded processors, improving system boot times and enhancing overall performance. Leverage electronic design, analysis and library tools including Cadence OrCAD, Cadence Allegro, and HyperLynx. Utilize Design for Manufacturing (DFM), Simulation Based Design (SBD), Design for Assembly (DFA), First Product Approval (FPA), Value analysis and Value Engineering (VAVE) methodologies. Utilize Plastic Injection molding and Metal casting, ensuring dimensional accuracy and reducing scrap rates. Responsible for Failure Mode and Effect Analysis (FMEA), and Design Verification Plan and Report (DVP&R) identifying and mitigating high-risk failure modes, resulting in significant reduction in warranty claims. Position is required to be on site in Lafayette, CO, four days per week. #LI-DNI

Basic Qualifications:

Bachelors' Degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and six (6) years of progressive post-baccalaureate experience as a manufacturing or analyst engineer or engineering manager. Must possess at least six (6) years' experience with each of the following: Directing cross-functional engineering teams including Mechanical, Hardware, Electrical, Electronics engineers providing strategic technical guidance and mentorship. Leveraging offshore teams across multiple geographies successfully launching electro-mechanical products, through streamlined collaboration and process optimization. ISO 9001 and IEC standards including 60601-1, 60601-1-2, 60601-1-8, and 60601-2-2). EMC and ESD testing protocols and design techniques. Designing and validating custom digital, analog, and power electronic circuits, integrating high- voltage/high-current systems and off-the-shelf components. Delivering embedded solutions [TH1.1]. DFM, DFA, SBD, FPA, and VAVE. Plastic injection molding and metal casting processes. FMEA and DVP&R plans

The position is located at Covidien LP (a Medtronic company), 200 Medtronic Dr. Bldg. 2, Lafayette, CO 80026. Relocation assistance is not available for this position. Position is required to be on site in Lafayette, CO, four days per week.

Salary: $215,000 to $256,800 per year

#LI-DNI

The following benefits and additional compensation are available to all regular employees:Incentive plans, 401(k) plan plus employer contribution and match,Short-term disability,Paid time off,Paid holidays,Employee Stock Purchase Plan,Employee Assistance Program,Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), andCapital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below: Medtronic benefits and compensation plans

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