Position Title
Sr. Product Development Engineer - MA
SBU
OEM
Department
Engineering
Relocation Covered
NO
Educational Requirements
Bachelor's degree
Experience Requirements
-Working knowledge of manufacturing processes related to medical device manufacturing
-Ability to prioritize and work independently as a self-starter with strong proactive work ethics
-Experience with design controls, FDA regulation, GMP practices, and QSR requirements
-Proficient in Microsoft Office and Microsoft Project
-Excellent working knowledge of GD&T with proficiency in Solid Works
-Experience with Risk Analyst tools and procedures
-Proven track record in product development, design, and working closely with manufacturing
-Demonstrated customer relations, problem solving, and product development skills
-Ability to influence across boundaries, drive collaboration, and develop product to meet the end users expectations
-Must be well-organized, detail-oriented, with excellent oral and written communication skills
Qualification Requirements
-BS Mechanical Engineering, or the equivalent in a related field
-10 years experience in Medical Device manufacturing
Preferred Qualifications
-Experience with sutures, textiles, and absorbables.
Responsibilities
This positions responsibility is for new business, developing new products, while interfacing with customers, vendors, and internal departments in order to achieve the desired product specification. The goal is to develop products, define specifications, to establish reasonable time lines while developing high quality products that meet the end users expectations. Relies heavily on meeting dates, accountability while using experience and judgment to develop products and meet goals with minimal supervision.
ESSENTIAL DUTIES AND RESPONSIBILITES:
-Develop products and processes that are reliable as well as identify risks to the project, develop contingency plans, while outlining deliverables and milestones
-Directs and coordinates activities to develop products and ensure progress as the product specifications/limitations are developed into the technical specification
-Review and prepared status reports, modify schedules, and project plans as required
-Keeps management, customers, and others informed of project status and/or related issues
-Provide technical leadership, root cause analysis, and resolve customer or project related problems; materials, assembly, functional, or manufacturing related
-Apply design controls from initial customer requests throughout the products life cycle
-Intimately involved with developing protocols, including verification and validation testing, drawings, calculation and/or FMEA etc...to develop and support technical documentation
-Collaborates to develop quality assurance, testing, regulatory compliance, and quality plans
-Address customer’s issues: improve performance, appearance, and impact on end-user
-Travel 15-20%
