Description:

The Manufacturing Engineer will have a hands-on role supporting and improving manufacturing processes for innovative single use medical devices for therapeutic applications. The position offers the unique opportunity to partake in an early stage start-up company with career advancement opportunities. The right individual is eager to face engineering challenges and participate in ongoing process and equipment improvements.

Skills:

Essential Duties and Responsibilities:

• Analyze and improve manufacturing process flow and floor layout to enhance safety, quality and efficiency

• Troubleshoot equipment problems and develop corrective actions

• Draft and execute validation protocols (IQ, OQ and PQ)

• Establish standard work and standard equipment operating parameters and properly document work instructions and standard operating procedures with clear and concise wording.

• Analyze quality problems and develop solutions and improvements

• Work with product development team to design manufacturing tooling and fixtures

• Support characterization and optimization of production processes though DOE, window studies, cycle time studies, etc., and properly document using laboratory notebook and/or technical study reports.

• Develop, implement, scale, verify, and validate manufacturing cells and processes

• Develop and implement automation solutions

• Work with Quality Control to resolve production and supplier quality issues

• Responsible for achieving device manufacturing and engineering operational objectives in support of commercial production, clinical trials, and new product development.

• Directly support production staff to ensure compliance with all Good Manufacturing Practices and Standard Operating Procedures as defined by the Company’s policies, practices, and procedures.

Qualifications:

• BS in Manufacturing, Mechanical, Industrial, Chemical, or Plastics Engineering

• 3 years of experience in an equipment-intensive medical device manufacturing environment

• Proficient with SolidWorks with a demonstrated ability to design fixtures and tooling is preferred

• Experience with plastics processing (extrusion, injection molding, fiber forming) is preferred

• Exposure to ISO 13485 standards is a plus

• Demonstrated ability to stay organized and implement organizational skills into their team members

• Strong verbal and written communication skills are essential

• Ability to respond to changing priorities and to multi-task, in a dynamic environment

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.