• Job Title: Program Manager
• Company Name: Biomerics - BAC
• Location: Brooklyn Park, MN
• Position Type: Full-Time Employee
• Pay: Salary DOE (any salary or pay ranges that may appear on our job postings are strictly estimates provided by that career site)

Company Overview: Biomerics Advanced Catheter (BAC) is located in Brooklyn Park MN. As an integral part of the Biomerics family of companies; BAC specializes in the design, development, and production of medical devices for minimally invasive diagnostic and interventional procedures. Our Advanced Catheter Division is focused on next-generation solutions for the cardiovascular, structural heart, cardiac rhythm management, electrophysiology, and vascular access markets. BAC's core capabilities include design and engineering services, advanced components, and full contract manufacturing of finished devices.

At Biomerics, our core values are embedded in everything we do: Integrity, Partnership, Empowerment & Accountability, Trust, Agility, Teamwork, Excellence, and We Care.

JOB DESCRIPTION:

The Program Manager will be responsible for leading the development of class II surgical devices in a dynamic, customer focused organization. You will 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). 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.

JOB RESPONSIBILITIES:

• Work within the constraints of budget, schedule, and scope while managing risk and ensuring adherence to established processes and regulations.
• Interacting with customers, suppliers, and internal resources.
• Demonstrating advanced knowledge of project and program management principals.
• 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 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.

JOB REQUIREMENTS:

• BS in Engineering or related field (Mechanical, Biomedical, Chemical) (Required).
• A minimum of 7+ years of related work experience in the medical device field (Required).
• The ability to lead a team toward operational objectives with 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) (Preferred).
  • 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).

Benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k with match.

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