As part of a multidisciplinary product development and manufacturing engineering team the Senior Mechanical Engineer will be responsible for mechanical engineering for a wide variety of projects in the field of medical device products.
The Senior Mechanical Engineer will set establish technical approach, select materials, conduct design reviews and create and execute test plans. With existing products, he/she will work in a value and manufacturing engineering capacity, reviewing prints, materials selection and manufacturing methods to assure accuracy, cost control and manufacturability. This role includes collaborating with and advising engineers and designers from client companies.
DUTIES AND RESPONSIBILITIES:
Work as a key part of the product realization team, establishing technical approach, evaluating risk and providing mechanical engineering solutions that meet or exceed the established product requirements.
Review and select materials, finishes and manufacturing methods for plastics, metals, and/or components.
Work with regulatory and program management staff to ensure mechanical engineering and design meets government regulatory guidelines and requirements.
Collaborate with electrical engineering and design to specify and create electro-mechanical parts, assemblies and products as appropriate.
Collaborate with clients and mechanical designers to specify and/or review mechanical drawings and assemblies for accuracy, cost management and manufacturability.
Work with mechanical designers and outside suppliers to create, modify, and assess part and/or product prototypes.
Review proposed manufacturing processes, dies and tooling to ensure efficient, accurate and cost-effective production of parts and products
Prepare and execute design verification tests ensuring product requirements have been fulfilled by execution of the technical approach.
Research and evaluate materials, components, assemblies, manufacturing procedures & processes and/or equipment.
Lead or participate in design reviews, ensuring product requirements are met, engineering intent is maintained, and risks are mitigated prior to release for tooling and production.
Other duties as assigned.
Bachelor’s Degree (B.A.) from a four-year college or university.
5 years related work experience including project level mechanical engineering.
3 yrs experience designing and/or performing process development of deflectable catheters.
Understanding of the general requirements and testing of catheters/introducers.
Knowledge of the processes of braiding, extrusion, and coil winding.
Strong materials, design and manufacturing knowledge of plastics (extrusions, injection molding and/or precision parts), stamping, casting and/or sheet metal fabrication.
Demonstrated ability to collaborate with, support and direct mechanical designers, review CAD models, part drawings and BOMs for accuracy and manufacturability.
Willingness to work with electronic document and project management systems to track work product, deliverables and progress.
Demonstrated ability to provide complete and accurate work product; material selection, designs, drawings and other documents that accurately reflect product requirements and transition smoothly into production.
Strong work ethic and professional commitment
The desire to both innovate and serve internal and external customers by meeting and exceeding project deliverables and timelines
Solidworks experience, preferred