Sr. Process Development Engineer

Cirtec Medical - Brooklyn Park, MN

Full-time - Mid Level

Brooklyn Park, MN

Miscellaneous Manufacturing

About the position

The Senior Process Development Engineer position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities

• Attends and arranges project meetings to discuss current and future design and development initiatives
• May serve as a primary contact with clients on projects of moderate complexity
• Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner
• Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions
• Track and communicate project status, plans, issues, timelines, action items, and budgets
• Provide guidance and direction to coworkers on areas of technical expertise
• Troubleshoot production processes as required
• Evaluate and select appropriate test methods for product requirements
• Responsible for the following project inputs: Feasibility builds, documentation, and testing, Equipment selection, process development and documentation, Device Verification samples and testing, Operator training, Process Failure Mode Effects Analysis, Clinical builds, Process Validation
• Involvement in the full design, development, and validation requirements of projects, including: Product design and specification creation, including mechanical and electrical components, assemblies, and packaging, Materials sourcing and device prototyping, Design verification and validation activities, including data for regulatory submission, Manufacturing transfer and support of existing product lines as applicable

Requirements

• A Bachelors degree in an engineering discipline
• At least 5 years of relevant experience in Process Engineering
• Experience in an engineering/manufacturing environment with a mix of mechanical design, tool design and manufacturing process experience
• Ability to train new engineering employees on project engineering activities and Cirtec policies and procedures
• Must be able to read, write and speak fluent English
• Strong computer skills, including the MS Office suite and MS Project
• Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents
• Strong analytical skills, must be able to obtain and evaluate secondary research information
• Ability to learn and apply new technology
• Moderate knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics

Nice-to-haves

• Previous Medical Device Experience

Benefits

• Training and career development
• Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid Time Off
• 401(k) retirement savings with a company match