- Job Title: Program Manager - Sr. Design & Development Engineer
- Company Name: Biomerics
- Location: Salt Lake City, UT (relocation is not offered, seeking local candidates)
- Position Type: Full Time Employee
- Salary: D.O.E. (any salary or pay ranges that may appear on our job postings are strictly estimatesprovided by that career site)
Company Description: Biomerics is a world-class contract manufacturer 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 the vascular access, electrophysiology, cardiac rhythm management, urology, neurovascular, structural heart, and cardiovascular markets.
Job Description: The qualified Program Manager - Sr. Design and Development Engineer candidate will be responsible for leading the development of Class II Medical 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).Biomerics is the contract manufacturing and product development partner for many of the world's top medical device companies, offering candidates a breadth of opportunity in a variety of product markets.
The qualified candidate may function as an individual contributor at times (working manager) and will lead a 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 support the transfer of the developed products to production. Project leadership may span multiple Biomerics facilities and external partners. The candidate will work within the constraints of budget, schedule, and scope while managing risk and ensuring adherence to established processes and regulations.
Roles and Responsibilities Include:
- Providing engineering services in a phased development approach to develop & launch medical devices.
- 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.
- BS in Engineering or related field (Required); Mechanical or Biomedical Engineering degrees preferred.
- Must have 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).
- The ability to perform statistical analysis (Required).
- Experience developing designs and testing via a phase-gate analysis (Concept, Feasibility, Design Verification) using a risk-based approach (dFMEA), including:
- Subject matter expertise in medical device development (Preferred).
- Development of reinforced shafts and sheaths, including steerable catheters(Highly Preferred).
- Proficiency in solid 3-D modeling (i.e. SolidWorks) (Preferred).
- Design for manufacturability and assembly (Preferred).
- Creation of risk assessments & failure modes and effects analysis (RA/FMEA) (Preferred).
- Experience with medical process validation, including:
- Coordinating validation definition and execution (IQ, OQ, PQ), test method definition, root cause analysis, gage R&R, and measurement systems analysis (MSA) (Preferred).
- Root cause analysis and structured problem solving (Required).
- Understanding of the design for plastic injection-molded components as part of medical device 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)