DescriptionPosition Summary: The Process Development Engineer II position is primarily responsible for designing, developing, and qualifying manufacturing processes, consisting of multiple engineering disciplines, for the manufacture of medical devices. The position will be involved in the design, development, documentation, and validation and 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
Key Responsibilities:- Attends and arranges project meetings to discuss current and future design and development initiatives.
- Serve as a primary contact with customers on programs of low to moderate complexity and serve as secondary contact with customers on programs of moderate to high complexity.
- Track and communicate the status of assigned action items that would affect timelines and budgets.
- Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
- Assist in the preparation and maintenance of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Provide input to program management for tracking and communicating project status, plans, issues, timelines, action items, and budgets.
- Responsible for the following project inputs:
- Feasibility builds, documentation, root cause analysis, and testing,
- Equipment selection and qualification,
- Process development and documentation,
- Device verification and samples testing,
- Operator training,
- Process failure mode effect analysis,
- Clinical builds,
- Process validation.
- Involvement in the full design, development, and validation requirements of programs, 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 and regulatory submission,
- Manufacturing transfer and support of existing product lines as applicable.
- Reliable, consistent, and punctual attendance is an essential function of the job.
- Complies with company, quality and safety standards, policies, and procedures
- Other duties as assigned
Must Have:- A Bachelor's degree in a STEM engineering discipline
- 2 years of experience; or a combination of education and relevant work experience in a STEM field.
- Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred)
- Willingness to travel, if required
- Must maintain high ethical standards
- Must demonstrate good organizational skills
- Must be able to read, write and speak fluent English
- Strong computer skills, including MS Office
- Experience with Minitab and statistical analysis
- Experience with documented change control processes.
- Must be able to fully interpret technical drawings, blueprints, specifications & illustrations
- Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information
- Ability to learn and apply new technology
- Technical report preparation and formal presentation skills
We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.
