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Sr. Design and Development Engineer, PROGRAM MANAGER

Biomerics Brooklyn Park, MN

  • Expired: over a month ago. Applications are no longer accepted.
Job Description
  • Job Title: Sr. Design and Development Engineer, Program Manager
  • Company Name: Biomerics - BAC
  • Location: Brooklyn Park, MN (seeking local candidates, relocation is not offered)
  • Job ID: 260390
  • Position Type: Full-Time Employee
  • Salary: D.O.E. (any salary or pay ranges that may appear on our job postings are strictly estimates provided by that career site)

Company Description: Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in the design, development, and production of medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, urology, neurovascular, structural heart, and cardiovascular markets.

Job Description:

The qualified Sr. Design and Development Engineer, Program Manager candidate will be responsible for leading the development of Class II Surgical Devices in a dynamic, customer-focused organization. The qualified candidate will be expected to work with customers to develop design input specifications and design, build, and test devices to those specifications. All activities will be expected to be documented according to design control requirements in a design history file (DHF).

The qualified candidate may function as an individual contributor and lead a small cross-functional team comprised of engineering, operations, and quality members to develop detailed engineering specifications, perform device design and development, and support verification, validation, and regulatory submissions of these devices, then transfer the products to production.

The candidate will work within the constraints of budget, schedule, and scope while managing risk and ensuring adherence to established processes and regulations. This is a hands-on engineering role with leadership requirements.

Roles and Responsibilities Include:

  • Interacting with customers, suppliers, and internal resources.
  • Demonstrating advanced knowledge of project and program management principles.
  • Using project management tools to manage medical device development projects.
  • Mentoring other project managers.
  • Defining and managing scope, time, and resources of large-scale, complex projects or programs.
  • Facilitating the identification of project or program risks, developing and assigning responsibility for mitigation actions, and managing the mitigation plan.
  • Refining project management methodologies for quality and project or program risk management.
  • Synthesizing critical information and communicating business implications to stakeholders.
  • Providing engineering services in a phased development approach to develop & launch medical devices.

Requirements:

  • BS in Engineering or related field (Mechanical, Biomedical, Chemical) (Required)
  • A minimum of 10+ years of related work experience in the medical device field (Required)
  • The ability to lead a team toward operational objectives with the aptitude to contribute to strategic goal-setting for department/business unit (Required)
  • Experience working through all aspects of medical device design & development including design verification and validation, process validation, and technology transfer (Required)
  • Must be able to function with little or no supervision (Required)
  • A Six Sigma Green/Black Belt (Preferred)
  • The ability to perform statistical analysis using k-factors, Ppk, and DOEs along with root cause analysis (Required)

Experience developing designs and testing via a phase-gate analysis (Concept, Feasibility, Verification) using a risk-based approach (dFMEA), including:

  • Subject matter expertise in a directly applicable sub-field (e.g. medical device development, mechanical assembly, catheter systems, injection molding, extrusions, electro-mechanical, etc.) (Preferred)
  • Development of reinforced shafts and sheaths, including steerable catheters (Preferred)
  • Proficiency in solid 3-D modeling (i.e. SolidWorks) (Required)
  • Design for manufacturability and assembly (DFMA) (Preferred)
  • Creation of risk assessments & failure mode element analysis (RA/FMEA) (Preferred)

Must have experience with medical process validation, including:

  • Supporting validation definition and execution (IQ, OQ, PQ), test method definition, root cause analysis, gage R&R, and measurement systems analysis (MSA) (Required)
  • Root cause analysis and structured problem solving (Required)
  • Experience and understanding of the design for plastics injection-mold fabrication processes (Preferred)
  • The ability to perform statistical analysis to ensure quality output of components & assemblies (Preferred)

Biomerics offers the following benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, 9 Paid Holidays, 401k, Onsite Fitness Facility

Please, No Recruitment/Agency calls or emails (we are not using recruitment services for this or any other role posted)

Biomerics

Address

Brooklyn Park, MN
USA

Industry

Engineering

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