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Finish Line Staffing Services
Published
November 29, 2021
Location
Salem, MA
Category
Job Type

Description

Our client, a designer and manufacturer of surgical equipment and solutions, is looking for an experienced Senior R&D Engineer. This is a senior tech-lead role within the R&D department and provides leadership for cross-functional teams to design and develop new products that drive down manufacturing cost and lead times and meet market needs.  The candidate is responsible for developing technology & component strategies for new products, while also identifying opportunities to improve existing products.  The R&D Engineer will be developing new technology, products, materials, processes, or equipment with minimal supervision. Working independently, or as a member of a team, the Engineer will develop, direct and execute plans for a major segment of complex projects.

Responsibilities:

  • Translate customer needs into product requirements and design specifications.
  • Consistently generate innovative and unique solutions to market needs and submits idea disclosures resulting in the development of new or refined products, processes, or equipment.
  • Interface with Physicians to obtain feedback on concepts and performance of new devices.
  • Work cooperatively with marketing, quality, manufacturing, regulatory and other functions on complex projects to ensure successful New Products to be developed.
  • Coordinate, manage and document project goals and progress of an R&D team and recommends appropriate actions.
  • Assess the feasibility and soundness of proposed products, engineering evaluation tests, and equipment.
  • Responsible for engineering documentation, especially Design History File (DHF).
  • Successfully completes complex engineering work and documentation in one or more of the following: technology development, product design and development, test of materials or products, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
  • Select techniques to solve complex problems and makes sound design recommendations.
  • Summarize, analyzes, and draws conclusions from complex test results.
  • Design and prepare complex reports to communicate results to technical community.
  • Designs and coordinate complex engineering tests and experiments

Areas of Focus:

New Product Development

  • Research and analyze information such as customer requirements, standards, and industry trends to determine feasibility of design or application.
  • Interface with health care professionals on product requirements.
  • Designs, develops, analyzes, and documents product designs in accordance with ISO, FDA, and corporate design control guidelines
  • Coordinate and lead a cross-functional team from prototype stage through pilot manufacturing including manufacturing process validation.
  • Knowledgeable in state of the art manufacturing processes (plastics, 3-D printing, etc.)
  • Perform and report on evaluation testing, verification, and validation in accordance with ISO, FDA, and company design control guidelines.
  • Knowledgeable on design for reliability
  • Accurately predict the time required for project tasks; help assure the scheduled time is met or improved to meet company objectives.

Communication and Leadership

  • Serve as the project team leader throughout the New Product Development process, identifies critical technical challenges, defines schedules, assigns tasks, and quantifies progress against project goals.
  • Effectively communicate information to peers, customers, and suppliers in order to facilitate project goals.
  • Serve as a mentor to other engineers in the company, helping them to develop their design, analysis, and problem-solving skills
  • Represent the company and R&D department on behalf in technical conferences, committees and meetings with medical professionals, technologists, attorneys, etc.

Quality

  • Utilize company design control procedures and project management techniques to effectively drive development of new, high-quality devices, or product improvements.
  • Adhere to all company policies, rules, procedures, and housekeeping standards

Minimum Qualifications:

  • BS or MS in scientific / technical discipline such as Mechanical, Biomedical Engineering
  • Minimum 6-10 years of related experience in the medical device industry developing Class II Medical devices
  • Minimum 3 years of Technical Management or Project Leadership experience
  • Must have demonstrated knowledge of regulations and standards effecting medical product development.
  • Experience translating customer needs to product requirements; and developing DHF deliverables like Product-spec, Risk Management, Verification & Validation, etc.
  • Strong ability to interact and collaborate with physicians in the field, preclinical studies, with hands-on capability in the lab
  • Knowledge of ISO, FDA, GMP and design control process is required
  • Knowledge of IEC standards and testing.
  • MEs must be proficient in Solidworks.
  • Demonstrated knowledge of Product Design for Assembly (DFA)

Preferred Qualifications:

  • Experience as project Core Team Leader
  • Experience developing Electro-Mechanical Products for Minimally invasive surgery
  • Demonstrated technical decision making
  • Proven success with delivering Manufacturable concepts to Production and launch into market
  • Effective communication skills required due to support of cross functional projects within a team
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