Mechanical Engineer II

Job Description

Job Description

Job Title: Mechanical Engineer II

Department: Engineering

Reports to: VP, Mechanical Engineering

FLSA Status: Exempt

Job Summary and Objective:

The Mechanical Engineer II will collaborate with team members to design and refine cutting-edge medical devices, contributing to product testing, validation, and optimization. Working closely with management, quality assurance, supply chain, and engineering teams, the Mechanical Engineer will oversee all stages of product development, encompassing mechanical design, materials sourcing, prototype fabrication, and the planning and implementation of characterization tests. Responsibilities will also include the development of test protocols, active participation in product testing, and the preparation of comprehensive test reports

Essential Duties and Responsibilities:

· Collaborate in the mechanical design and development of diverse medical devices.

· Create robust solid models, drawings, and detailed specifications.

· Conduct thorough characterization and environmental tests to validate the design and performance of devices.

· Interface with suppliers to select critical components and qualify tools.

· Strategize and coordinate activities to achieve results and meet crucial deadlines, translating client requirements into project milestones.

· Coordinate closely with operations and quality teams to ensure adherence to design specifications.

· Ensure engineering projects and processes align with the organization's policies and objectives.

· Engage in cross-departmental project discussions to identify and resolve design-related issues.

· Prepare and review necessary documentation for product feasibility and design, ensuring compliance with client and industry specifications.

· Identify and mitigate risk associated with device functionality, reliability, safety, COGs, and manufacturing scalability.

· Design and evaluate feasibility of improved device components, subsystems, and assembled products.

Supervisory Responsibilities:

· Does not regularly supervise employees.

· May oversee other employees for isolated or specific tasks.

Required Qualifications and Work Experience:

· Bachelor's Degree in Mechanical Engineering (B.S., M.E.)

· 5+ years of experience in design engineering

· Proficiency in SolidWorks design software

· Demonstrated leadership in developing new products, technologies, and associated processes

· Experience in injection molding, metal forming, welding, and other metal and plastic joining methods

· Experience with design for automation

· Excellent communication skills

· Proficient in Microsoft Project and Microsoft Office suite

· Working knowledge of FDA Quality System Regulation (QSR) and ISO 13485 guidelines related to Design Controls

· Strong written and verbal communication skills

· Ability to work independently with minimal supervision and consistently achieve goals

Preferred Qualifications and Work Experience:

• M.S. Degree in Engineering

• 7 + years of medical device engineering experience

• 5+ years’ experience in FDA and ISO 13485 design and manufacturing environment

• Expert Design Certification from SolidWorks

• Electro-mechanical instrumentation and robotics operations

Physical Demands:

· Full range of motion for wrist, hand, and finger dexterity

· Comfortable with prolonged sitting and working at a computer

· Proficient in an engineering lab environment

· Working in a cleanroom environment

Work Environments:

· Physical Setting: Busy, professional office environment.

· Culture: A diverse and inclusive culture that respects and values individual contributions. Our team engages in regular social events to foster relationships.

· Dress Code: Business casual attire to promote a professional yet comfortable workplace.

· Core Business Hours: 8:00am to 5:00pm.