Program Manager

Job description

Biomerics is a world-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 designing, developing, and producing medical devices for diagnostic and interventional procedures.

We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

At Biomerics, we are dedicated to our diverse employee base.

We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business.

We strive to live up to Biomerics' values in all our interactions.

It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics.

We improve and advance the lives of our employees and the patients who depend on our products.

At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care.

Our team-oriented, customer-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.

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.

- BS in Engineering or related field (Mechanical, Biomedical, Chemical) is highly desired or a combination of work history in the medical device field

- 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:

o 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).

o Development of reinforced shafts and sheaths, including steerable catheters.

(Preferred)

o Proficiency in solid 3-D modeling (i.e. SolidWorks) (Preferred).

o Design for manufacturability and assembly (DFMA) (Preferred).

o Creation of risk assessments & failure mode element analysis (RA/FMEA) (Preferred).

- Must have experience with medical process validation, including:

o Supporting validation definition and execution (IQ, OQ, PQ), test method definition, root cause analysis, gage R&R, and measurement systems analysis (MSA) (Required).

o Root cause analysis and structured problem solving (Required).

o Experience and understanding of the design for plastics injection-mold fabrication processes (Preferred).

o 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, Paid Holidays, and 401k.

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

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- The salary estimates are estimates from this job board and not a guarantee of Biomerics’ salary range.

- Biomerics does not accept non - solicited resumes or candidate submittals from search/recruiting agencies that are not already on Biomerics' approved agency list.

Unsolicited resumes or candidate information submitted to Biomerics by search/recruiting agencies not already on Biomerics approved agency list shall become the property of Biomerics.

If Biomerics subsequently hires the candidate, Biomerics shall not owe any fee to the submitting agency.

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Required Skill Profession

Operations Specialties Managers