This is a Senior R&D Engineer role within the R&D department at a medical device company 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 behalf of the Company 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
Non-Essential Functions :
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
Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.
Help us improve CareerBuilder by providing feedback about this job:
Report this Job
Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to ourTrust and Site Security Team
Job ID: 21-71702
privacy and protection,
when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction.Learn more.
By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder
Terms and Conditions
for use of our website. To use our website, you must agree with the
Terms and Conditions
and both meet and comply with their provisions.