Supervisor, Engineering (Collagen) - Wayne, NJ

Company: Getinge
Location: Wayne
Posted on: May 16, 2022

Job Description:

Position Overview

Responsible for identifying, verifying, validating, and implementing Collagen OEM and Medical Devise products. Manage and coordinate engineering personnel and technical support to all areas of the Company. Work cross-functionally to lead design change management and ensures efficient and effective commercialization and transfer of product changes into production.

Job Duties
Conduct and manage complex engineering and technical support projects.
Support the development of project plans including the proposed technical approach, budget, and key milestone completion dates for all assigned projects. Initiate appropriation requests for projects.
Manage projects by tracking progress, assigning staff and coordinating activities to ensure timely and cost effective project completion in accordance with established objectives.
Manage engineering and senior engineering professionals and complex/critical design changes. Supervise other operators and engineers and serve as liaison to other company sites or to external organizations, boards, or committees.
Prepare technical reports, analysis, recommendations and presentations reflecting the status and results of projects in progress on a regular basis.
Lead and ensure all design changes/improvements are appropriately validated and documented to ensure compliance with all regulatory requirements.
Perform technical and product-related sustaining activities using knowledge of biomaterials, Design Controls, engineering principles and compliance writing
Responsible for creating technical specifications for new product or product improvements.
Prepare experimental protocols and reports in response to development needs.
Evaluate prototypes, collect, analyze and report data.
Perform basic remediation activities using Design Controls principles, new product development knowledge and our internal procedures.
Identify and record any problems relating to the product, process and quality system.
Provide technical support for product registrations using product knowledge and the scientific literature.
Assessment of industry standards to ensure compliance

Background Experience
Bachelor's Degree in Engineering (preferably Biomedical or Chemical Engineering), or related field, or possess the equivalent combination of education and experience
Minimum of 5 - 10 years of medical device industry experience, preferably in a lead new product development engineering position
Experience/familiarity with U.S. FDA, GMP, and ISO requirements for the design, validation, manufacturing processes and assembly of medical components and devices
Experience with tissue-based technologies or experience developing or refining biological implantable materials preferred

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

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