Description:

Be actively involved in selecting, sourcing, testing and approving materials to achieve specifications and reliability requirements

Design, develop and modify processes and methods for the manufacture, molding and utilization of metallic, plastic, composite and other materials in construction and production of hardware, electronic components and structures

Determine design approaches and parameters and analyze mechanical systems, equipment and packaging

Lead and execute experimental and feasibility tests. Develop and execute test methods for product evaluation and validation.

Create ECOs’ (Engineering Change Orders), Plans, Protocols and Prototypes under broad direction.

Support qualification of new products / process / testing and inspection, and ensure compliance to quality standards through the creation and execution of protocols

Create and maintain design-related technical documentation for building a complete design history file

Supports timely introduction on any new products or product upgrades in the designated business area; including development of product costs (COGS)

Ensure implementation and approval of all aspects of Design Control including integrated design plan, design inputs, verification and validation according to corporate design control procedures.

Direct support personnel in the preparation of detailed design, design testing and prototype fabrication.

Complete activities other assigned activities such as CAPAs, complaint investigations and first article inspections

Skills:

design control, technical writing, catheter, glass fiber, class 3

Top Skills Details:

design control, technical writing, catheter, class 3

Additional Skills & Qualifications:

Bachelor of Engineering with working knowledge of engineering principles and at least 5 years’ related experience and/or training in sustaining/manufacturing engineering in the medical device industry

Demonstrated medical device design experience required specifically with sterile medical devices; catheter experience preferred

Demonstrate good approach to problem solving and project management

Knowledge and Interpretation of FDA guidelines and ISO 13485 requirements

Demonstrated utilization of Design for Six Sigma, Design for Manufacture/Assembly and Design for Test methodologies highly desirable

Experience Level:

Expert Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.