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Title: Senior R&D Engineer
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration – Permanent
- Pay rate: 115-130K
- Job Location: Beverly, MA
- Job# bh12036
Sr. 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.
- Responsible for developing technology & component strategies for new products, while also identifying opportunities to improve existing products.
- Responsible for developing new technology, products, materials, processes, or equipment with minimal supervision. Independently, or as a member of a team, develops, directs, and executes plans for a major segment of complex projects.
The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity.
- Translates customer needs into product requirements and design specifications.
- Consistently generates innovative and unique solutions to market needs and submits idea disclosures resulting in the development of new or refined products, processes or equipment.
- Interfaces with Physicians to obtain feedback on concepts and performance of new devices.
- Works cooperatively with marketing, quality, manufacturing, regulatory and other functions on complex projects to ensure successful New Products to be developed.
- Coordinates, manages, and documents project goals and progress of an R&D team and recommends appropriate actions.
- Assesses 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.
- Selects techniques to solve complex problems and makes sound design recommendations.
- Summarizes, analyzes, and draws conclusions from complex test results.
- Designs and prepares complex reports to communicate results to technical community.
- Designs and coordinates complex engineering tests and experiments
New Product Development
- Researches and analyzes 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
- Serves 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 our behalf in technical conferences, committees and meetings with medical professionals, technologists, attorneys, etc.
- 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
In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.
- 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).
- 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
Our client is seeking: Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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