Job description
This position will work directly with healthcare professionals, advanced manufacturing providers, as well as engineering teams across the globe, to realize the design requirements for novel medical devices. The Manufacturing Systems Engineer will also manage manufacturing and prototyping projects and demonstrate additive manufacturing technologies, providing knowledge, design feasibility studies, production workflow, and product commercialization expertise.
Responsibilities
● Liaise with service providers and technology centers for advanced and additive manufacturing to transfer expertise and communicate design requirements.
● Manage internal production and maintenance schedules for manufacturing tools.
● Support the development of medical devices, implants, and instruments from concept to market launch. Responsibilities will cover all aspects of the design process, including research, prototyping, laboratory testing, iterating, design for manufacturing, and detailed design of final parts and assemblies.
● Work in a collaborative environment, interacting with cross-functional teams (Product & Project Management, Quality/Regulatory, Operations, and Marketing).
● Develop product requirements and product specifications based on user requirements.
● Fabricate and test components and assemblies as needed for product development.
● Source appropriate vendors to manufacture products and oversee their procedures and workmanship.
● Create manufacturing process instructions, raw material specifications, and qualification/validation protocols and reports.
● Creation of test protocols/reports, design review reports, risk management reports, and other supporting documents to comply with the design control processes
● Perform verification/validation testing as required.
● Support all technical aspects of the product and instruments.
● Support regulatory and quality requirements in compliance to ISO 13485:2016 and FDA regulations.
● In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485:2016, or ISO14971), the employee has the responsibility to report any instances to their direct supervisor or above.
Qualifications
● 3+ years in additive manufacturing technologies
● Proficient with CAD software (SolidWorks preferred),, geometric dimensioning and tolerancing, and tolerance analyses.
● Proficient with additive manufacturing build preparation software such as Materialise Magics and 3DXpert
● Experience with analytical tools such as Finite-Element-Analysis is a plus.
● Must understand manufacturing processes including additive manufacturing.
● Experience with 3D printing technologies such as Laser Powder Bed Fusion, E-beam Powder Bed Fusion, Binder Jetting. from print to post-processing
● Experience with design thinking, rapid prototyping, and fabrication/assembly a plus
● Must demonstrate strong written and verbal skills with experience presenting technical information in a small group setting.
● Must work well in a small team and fast-paced environment.
● Have a track record for successful engineering projects through innovative engineering solutions and cost-effective manufacturing, followed by product support and improvement.
● Have a demonstrated ability to communicate effectively in multidisciplinary settings and work well with co-workers, surgeons, clinicians, regulators, and distributor representatives.
● Have a working cross-disciplinary understanding of a medical device business focused on engineering, manufacturing, operations, R&D, clinical and regulatory, and quality assurance.
● Be a proactive person who attacks problems, displaying initiative and perseverance to bring about meaningful change, and to be open and responsive to new ideas.
● Be known as a person who has high integrity, sound character, a tremendous work ethic and the passion to succeed.
Education Requirements
● B.S. required in engineering, design or equivalent work experience.
● M.S. in Mechanical or Industrial Engineering is a plus
● Must have a strong passion for product and process excellence and customer satisfaction.
● Medical device industry experience is strongly preferred.
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