Process Development Engineer
1 month ago
Description:
Develops, directs, and executes plans for major process related segments of complex product development projects. Compiles and analyzes process performance data to establish process design and specifications for newly designed or modified products. Plans and validates equipment and processes of newly designed products to internal and external requirements. Leads and oversees team supporting process development related activities on project. Reviews progress of projects; recommends appropriate revisions. Takes a leadership role in application and advancement of technologies. This specific role needs balloon catheter experience (i.e. laser bonding, balloon blowing, hot jaw bonding, leak test development), as well as direct manufacturing process validation ownership and experience.
Skills:
Process development, Medical device, catheter, Manufacturing engineering, Process improvement, Design, Process engineering, Continuous improvement, Manufacturing process, Lean manufacturing, Six sigma, iso 13485, iso 14971, Project management, Validation, kpi
Top Skills Details:
Process development,Medical device,catheter
Additional Skills & Qualifications:
- Oversee process design, development, characterization, and validation for products in development.
- Applies technical knowledge to innovate, design, & develop repeatable balloon catheter manufacturing processes.
- Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements.
- Perform engineering and technical work involved in planning, organizing, and coordinating detailed information required to develop new products from concept to final product realization.
- Develop and manage strategy to bring processes from feasibility to launch.
- Contribute to resource planning, customer acquisition and account management.
- Develops, writes, & reviews process validation strategy and related deliverables.
- Works cross functionally to lead, own, develop, & deliver capable and robust processes and equipment to operations.
- Contribute to early development phases and be the voice of design for manufacturability.
- Identify suitable processes and equipment early in development and ensure robust manufacturable product design.
- Work closely with other engineers, technicians, contract manufacturers, assemblers, or other support personnel to oversee manufacturing products for development prototypes, design verification, process development and validation activities.
- Identify critical processes, and develop master process validation plans including IQ, PC, OQ, PQ and external service validations requirements for development projects.
- Work closely with other engineers and assemblers to characterize and validate equipment and processes.
- Identify process inputs and outputs and develop strategy for how to monitor and control.
- Identify process performance requirements (yield, capacity, capability, efficiency) that should be met before transfer to production and may be used as KPIs.
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 (%20actalentaccommodation@actalentservices.com)
for other accommodation options.
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