Sr. Mechanical Engineer

Let’s work together.

Responsibilities

Design & develop products from concept to mass production
Design & prototype test fixtures and test equipment for R&D and mass production
Create and manage product/ project documentation throughout the product life cycle, in accordance with the company’s ISO13485 QMS including:

Product development plans (PDP)
Design inputs, product requirements, and design outputs
Design Verification & Design Validation Plans as well as supporting documents, reports, and matrices.
Failure mode effect analysis (FMEA)

Calculate (excel/ hand calcs) important design criteria, such as forces, stress, deflection, wear, etc and create FEA models/ simulations when necessary
3D CAD design for manufacturing, spanning a variety of processes, including milling, turning, and injection molding.
Create engineering drawings with GD&T best practices
Plan and manage design reviews and releases per the project schedule
Create and approve ECRs (engineering change requests)
Analyze manufacturing data for assigned projects to ensure requirements and quality metrics are met.
Manufacturing process & material research and development
CAM and operate CNC to produce prototypes and test fixtures (training will be provided)

Qualifications

5+ years of relevant experience in medical device design/ manufacturing
Bachelor’s degree in Mechanical Engineering or related fields
Lead engineer on product(s) that made it to series production
Proficiency in 3D CAD design, FEA, and 2D drafting/ drawings
Experience designing parts for a variety of machining processes
Experience with a broad range of finishing processes
Experience with medical device design & manufacturing documentation throughout the product development process
Experience with ISO13485 quality system
Self motivated and capable of driving and leading projects
Good planning and time management skills
Comfortable with and capable of solving very complex and ambiguous problems and managing multiple projects simultaneously

Nice to Have

Location