Company Description: Biomerics is a world-class contract
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, neurovascular,
structural heart, and cardiovascular markets.
The candidate will be responsible for managing the execution of
New Product Development (NPD) and New Product Introduction (NPI)
projects, regardless of scale, and may manage project managers
within assigned projects. The candidate will work within the
constraints of budget, schedule, and scope while managing risk and
ensuring adherence to established processes and methodologies. The
candidate will report to the VP of Engineering.
Roles and Responsibilities Include:
Interacting with customers, suppliers, and internal
Demonstrating advanced knowledge of project and program management
Using project management tools to manage large and complex projects
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.
Synthesizing critical information and communicating business
implications to stakeholders.
Supporting business development through meetings with prospective
customers and through developing technical relationships with other
A Bachelor's degree in a related field required (Mechanical,
Materials Science, Plastics, etc.) (Required).
A minimum of 5+ 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).
Must have experience working through all aspects of medical device
design/development including design V&V and process
validation/technology transfer (Required).
A PMP certification (Preferred).
A Six Sigma Green/Black Belt or ASQ CQE certification
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) compliant with 21CFR/ISO-14971, including: - Must be a
subject matter expert in a directly applicable sub-field (e.g.
injection molding, extrusion, electro-mechanical, etc.)
(Preferred). - Must be proficient in solid 3-D modeling (i.e.
SolidWorks 2010-2013) (Preferred). - Must understand design for
manufacturability and assembly/design for six sigma (DFMA/DFSS)
(Preferred). - Must be able to author/co-author risk assessments &
failure mode element analysis (RA/FMEA) per ISO-14971
Must have experience with medical process validation, including: -
Must be capable of supporting validation definition and execution
(IQ, OQ, PQ), test method definition, root cause analysis, gage
R&R, and measurement systems analysis (MSA) (Required). - Must
be familiar with root cause analysis and structured problem solving
(Required). - Experience and understanding of the design for
plastics injection-mold fabrication processes (Preferred). -
Experience and understanding of the development and design of
plastic parts, insert molded parts, and assemblies (Preferred). -
The ability to conduct design review(s) of hot/cold runner
injection molds (Preferred). - Experience and understanding of the
design for profile extrusion processes (Preferred). - Experience
and understanding of the development and design of single,
co-extruded, and braided profiles (Preferred). - The ability to
perform statistical analysis to ensure quality output of
molded/extruded components (Preferred). - The ability to establish
the parameters for an optimal molding environment (Preferred).
Competitive salary commensurate with experience Profit-sharing
bonus plan Attractive insurance and medical benefits.
2 weeks annual PTO 401k, company matching