International medical technology innovation and manufacturing company is a seeking a NPI Engineer to join their team in Irvine CA. The Engineer will be supporting projects to establish manufacturing and improve existing production processes for a range of technically complex products. One be be focusing on project management, client and internal stakeholder communication, as well as understanding the technical and regulatory background of both product and process to ensure informed decisions are made in an efficient manner.

Responsibilities

• Drive the establishment of manufacturing and processes for new products.

• Support initiatives to improve the manufacturing process of new and existing products with a focus on lean assembly.

• Preparation of dashboards and reports of key metrics.

• Communication with clients and managing client’s expectations.

• Development of task plans, schedules and improvements for review and approval by Manager.

• Reporting of progress and status of agreed forecasts, plans and agreed outcomes internally and to customers.

• Ownership of product drawings, process flow charts, risk assessments, part criticality lists, BOM management, supplier establishment and qualification, technical specifications, test fixture assembly, and test tool assessments etc.

• IQ, OQ and PQ, line validations on transfer products.

• Responsible for product and process change management in conformance with the PI QMS (ECR/ECO).

• EOL assessments, Equivalence studies (including verification plans and activities)

• Management of materials non-conformances and supplier improvements with the PI QMS.

• Responsible for driving RCA and implementation of CA and/or PA within the CAPA system.

• Ensuring compliance with ISO 13485 / ISO 9001 (QMS and Manufacturing standards).

Qualifications

• Bachelor’s degree in engineering or a related area of study and 2+ years of previous experience or equivalent.

• Demonstrated experience in new product establishment; transferring products from design to manufacturing through a systematic transfer process.

• Experience in change management and process improvement.

• Exceptional interpersonal, communication, and time management skills.

• Proven ability to work creatively and analytically in a problem-solving environment.

• Highly organized with acute attention to detail.

• Demonstrated ability to own tasks to meet deadlines and stay within budget.

• Strong team orientation and cross functional attitude.

• Experience working to policies; procedures and international quality standards, including ISO13485, ISO9001, or in a highly regulated industry.

Additional Information:

• Compensation: $100,000 to $120,000 per year

• Worksite: 100% onsite in Irvine facility

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.