Job Description:

A large plastics manufacturer of medical devices is looking for a product engineer to support their growing business. This individual will be responsible for creating design controls, come up with criteria that may not be clear to meet FDA standards, determine the control functional side of device to ensure it won't change end design.

The responsibilities that you will perform also include:

• Lead multiple large-scale projects at one time, ensuring schedules and deliverable expectations are met.
• Identify, scope, and present potential cost savings and efficiency opportunities to a cross-departmental review board.
• Oversee product improvement projects and manage project timelines.
• Manage projects including resource allocation.
• Become the subject matter expert related to specific products, manufacturing processes, and internal processes.
• Write, review, modify, and approve Process and Product validation documents per FDA guidelines.
• Create and modify existing product specifications based on global standards (ISO), and customer requirements.
• Train associates with work techniques, and skills required to perform product assembly or processing.
• Assist in maintaining Food & Drug Administration (FDA), Good Manufacturing Practices (GMP), and ISO Compliance.
• Support Design History Files (DHF), sustaining and product development on a project.
• Complete product line consolidations, design improvements, transferring manufacturing, line transfers
• Responsible for engineering & design aspect of the design controls
• Processes they support on-site in manufacturing: solvent bonding, automation, welding, etc. 

Skills & Qualifications:

• Bachelor’s Degree in manufacturing, industrial, mechanical, or related engineering.
• Knowledge of the design and development processes used for medical devices and experience in project management. Experience with manufacturing processes for plastic components such as injection molding knowledge is preferable.
• 7 years of experience in an engineering and/or project management position.
• Experience in a medical device, pharmaceutical, or plastics manufacturing facility is a plus.
• The candidate will have the ability to work with mathematical concepts and apply those concepts to practical situations; proficiency with standard computer software. Proficiency in project management tools such as MS Project is required. Knowledge of CAD software, specifically Solidworks, is highly desired. Exceptional communication skills required.

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.