NPI Engineer III

Cretex Medical Component and Device Technologies; Brooklyn Park (MN); On-site; USD 90,800 - 136,200; Full time

Benefits offered by this job

401k retirement savings plan

Comprehensive medical insurance

Employee assistance program

Wellness program with incentives

Job summary

Cretex Medical Component and Device Technologies in Brooklyn Park is seeking an experienced NPI Engineer lll. This role focuses on developing, validating, and launching new products while mentoring junior engineers. Responsibilities include process validation, documentation, and maintaining compliance with medical device regulations.

Qualified candidates must have a Bachelor’s degree in Engineering and at least 5 years of relevant experience. Benefits include a competitive salary and comprehensive health coverage.

Qualifications

• 5 years of engineering experience in a manufacturing setting.
• Experience in an ISO13485/GMP environment.
• Strong skills in statistical analysis and capability assessments.

Responsibilities

• Develop, validate, and launch new products into production.
• Conduct root cause analysis and troubleshooting on processes.
• Create and approve device routers and manufacturing procedures.

Skills

Mechanical Engineering

Process Design and Validation

Lean Manufacturing

Communication Skills

Project Management

3D CAD Software Proficiency

Statistical Analysis

Equipment Design

Education

Bachelor’s Degree in Mechanical, Industrial, or related Engineering

Tools

ProE

Unigraphics

Solidworks

Job description

Overview

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at www.cretexmedical.com.

Position summary

The NPI Engineer lll will be responsible for developing, validating, and launching new products into the production environment. Responsible for validating, designing, developing, and training for new products while working through a defined stage gate process. This position will also provide support to the NPI organization to provide mentorship and support cross functional projects between NPD, Quality, and Manufacturing.

Responsibilities

Essential Job Functions:

• Initiate and complete technical activities leading to new or improved processes or design for manufacturability for programs and to meet strategic goals and objectives of the company.
• Ideate process flow diagrams to map processes and assess efficiency, cycle times, yield, and scrap to provide quantitative data on the stability on new processes.
• Lead root cause analysis and troubleshooting efforts on equipment or processes to solve quality, consistency, and scrap problems.
• Analyze and solve problems from basic engineering principles, theories, and concepts through to a wide range of complex and advanced problems which require innovative approaches to validation and product design to meet customer deliverables.
• Create, maintain and approve device routers, bill of materials, and manufacturing procedures.
• Own development, characterization, and validation of new processes to output capable and stable processes using statistical analysis skills and tools (ex. DOE) where appropriate.
• Develop and lead discussions around risk documents such as pFMEAs and MVPs providing risk-based feedback to meet both quality and customer timeline requirements.
• Deep understanding of process validation (IQ/OQ/PQ) and statistical analysis including capability, confidence/reliability, etc. to provide high level planning and execution on validation activities
• Able to evaluate short-term project and process risks and react with appropriate speed and prioritization.
• Iteratively design, fabricate, test, and implement unique/complex process fixturing and gauging.
• Support new equipment identification initiatives including selection, justification, setup and training on new or novel pieces of equipment.
• Participate as technical lead in customer visits, key contact for customer projects
• Support cost evaluation in partnership with business development and technical solutions teams.
• Support identification/research of new technologies, equipment, and capabilities for the business
• Mentor and provide guidance to NPI Engineer I, II and Engineering Technicians
• Interface with Quality, Development, and Manufacturing organizations to integrate new products or processes into the existing production area.
• 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 we serve
• Ensure business systems are implemented, maintained, and functioning properly
• Participate in required company meetings
• Maintain an organized work area (5S)
• Participate in the Operational Excellence Program
• Complete all other work duties as assigned
• Ability to work in a manufacturing/cleanroom environment

Qualifications

• Bachelor’s Degree in Mechanical, Industrial, or other Engineering Science
• 5 years of engineering experience in a manufacturing setting; including state of the art manufacturing technology/concepts and cost reductions
• Experience in an ISO13485/GMP environment
• Engineering experience with medical devices
• Process design and validation
• Equipment and fixture/gauge design
• Lean manufacturing experience
• Team dynamic skills (communication, accountability, decision-making, feedback, meeting management, managing conflict)
• DOE, SPC, FMEA, GMP, QSR
• Knowledge of materials and related processes
• Project management experience
• Manufacturing automation, including electronic visual inspection
• Proficient in 3D CAD software (i.e. ProE, Unigraphics, Solidworks, etc.)
• Excellent communication and influencing skills
• High level of energy, personal accountability, and integrity
• Highly detail oriented; checks own work, keeps accurate records, organizes information effectively
• Ability to tolerate ambiguity, multiple priorities, and short deadlines
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
• Clear and effective verbal and written communication skills
• Attention to detail
• Organizational skills
• Ability to work in a fast-paced team environment
• Ability to prioritize and multitask

Pay Range

USD $90,800.00 - USD $136,200.00 / Yr.

Pay Range Details

This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range.

Company Benefits

All Employees:

Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees.

20+ hours:

Cretex’s medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week.

30+ hours:

Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week.

(Some benefits are subject to eligibility criteria.)

Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law.

Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.