NPI Engineer III

Cretex Medical Component and Device Technologies•Brooklyn Park, MN

11d•$90,800 - $136,200

About The Position

Cretex Medical is a contract manufacturer of precision components and assemblies for the medical device industry. The NPI Engineer III develops, validates, and launches new products into production through a defined stage-gate process. The role designs and validates new products and processes, supports training, and provides mentorship and cross-functional support across NPD, Quality, and Manufacturing. The engineer leads process development, characterization, and validation; evaluates process performance and risk; troubleshoots equipment and process issues; and creates manufacturing documentation. The position also supports equipment and technology initiatives, customer projects and visits, cost evaluation, and integration of new products and processes into production. The role requires working in a manufacturing or cleanroom environment and supporting the company Quality System, ISO, and medical device requirements.

Requirements

Bachelor’s degree in Mechanical, Industrial, or another engineering science.
Five years of engineering experience in a manufacturing setting, including experience with advanced manufacturing technologies or concepts and cost reductions.
Experience in an ISO 13485/GMP environment.
Engineering experience with medical devices.
Experience with process design and validation.
Experience with equipment and fixture/gauge design.
Lean manufacturing experience.
Team skills, including communication, accountability, decision-making, giving and receiving feedback, meeting management, and conflict management.
Knowledge of DOE, SPC, FMEA, GMP, and QSR.
Knowledge of materials and related processes.
Project management experience.
Experience with manufacturing automation, including electronic visual inspection.
Proficiency in 3D CAD software such as ProE, Unigraphics, or SolidWorks.
Excellent communication and influencing skills.
High energy, personal accountability, and integrity.
Strong attention to detail, including checking work, maintaining accurate records, and organizing information effectively.
Ability to tolerate ambiguity, manage multiple priorities, and meet short deadlines.
Proficiency with Microsoft Office, including Outlook, Word, Excel, PowerPoint, and Publisher.
Clear and effective verbal and written communication skills.
Strong organizational skills.
Ability to work in a fast-paced team environment and prioritize and multitask.
Ability to work in a manufacturing or cleanroom environment.

Responsibilities

Initiate and complete technical activities for new or improved processes and design for manufacturability, supporting program and company strategic goals.
Develop process flow diagrams and assess efficiency, cycle time, yield, scrap, and process stability.
Lead root cause analysis and troubleshoot equipment and processes to address quality, consistency, and scrap issues.
Analyze and solve engineering problems, including complex problems requiring innovative validation and product-design approaches.
Create, maintain, and approve device routers, bills of materials, and manufacturing procedures.
Develop, characterize, and validate new processes to achieve capable and stable output, using statistical analysis tools such as DOE when appropriate.
Lead discussions of risk documents, including pFMEAs and MVPs, and provide risk-based feedback in support of quality and customer timelines.
Plan and execute process validation activities, including IQ/OQ/PQ and statistical analysis of capability and confidence or reliability.
Evaluate short-term project and process risks and respond with appropriate prioritization.
Design, fabricate, test, and implement complex process fixturing and gauging.
Support identification, selection, justification, setup, and training for new equipment.
Serve as a technical lead during customer visits and as a key contact for customer projects.
Support cost evaluation with business development and technical solutions teams.
Research and identify new technologies, equipment, and business capabilities.
Mentor and guide NPI Engineer I and II employees and Engineering Technicians.
Work with Quality, Development, and Manufacturing to integrate new products and processes into production.
Support and comply with the company Quality System, ISO, and medical device requirements.
Read, understand, and follow work instructions and standard work.
Understand customer needs and the core business markets served.
Ensure business systems are implemented, maintained, and functioning properly.
Participate in required company meetings and the Operational Excellence Program.
Maintain an organized work area using 5S.
Complete other work duties as assigned.

Benefits

401(k) retirement savings plan with company match.
Onsite health clinics.
Discretionary holiday bonus program based on years of service.
Cretex University.
24/7 employee assistance program, including access to five confidential visits with a licensed counselor at no cost.
Wellness program with incentives.
Employee death benefit.
Employee sick and safe leave.
For employees working 20 or more hours per week: medical insurance with access to virtual providers, dental insurance, vision insurance, pre-tax health savings account, healthcare and dependent-care pre-tax reimbursement accounts, paid holidays, paid time off, and discretionary profit sharing.
For employees working 30 or more hours per week: parental leave, accident and critical illness benefits, optional employee, spouse, and child life insurance, short- and long-term disability, company-provided life insurance, and tuition assistance.