Project Manager-Engineer- New Product Development

Company: Biomerics
Location: Athens
Posted on: June 12, 2021

Job Description:

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.

Job Description:

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 resources.
Demonstrating advanced knowledge of project and program management principles.
Using project management tools to manage large and complex projects or programs.
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 engineers.

Requirements:

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 (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) 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 (Preferred).
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).

Benefits

Competitive salary commensurate with experience Profit-sharing bonus plan Attractive insurance and medical benefits.
2 weeks annual PTO 401k, company matching

Keywords: Biomerics, Tyler , Project Manager-Engineer- New Product Development, Other , Athens, Texas