Program Manager - Cretex Medical Component and Device Technologies

Overview
About Cretex Medical
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.
Program Manager Position Summary:
The NPI Program Manager leads the cross-functional engineering team for new product introduction, coordinating all facets of development from project inception through hand-off to production. The Program Manager is responsible for meeting program goals and objectives, managing the program financials and project timelines, customer communication, and managing project scope. This is an indirect leadership role with no direct reports.
Responsibilities
Program Manager Responsibilities:
- Administer and manage customer projects through the new product engineering stage gate process to meet requirements, scope, schedule, budget, and quality expectations
- Ensure compliance to the company Quality Management System (QMS), policies and procedures, regulatory agency standards and guidelines, and customer specifications throughout the development cycle
- Build and maintain a positive working relationship with internal and external customers
- Direct and assume responsibility for the actions and performance of the NPI cross-functional team. Facilitate teamwork between departments
- Create project plans/timelines and promote a sense of urgency to ensure successful commercial launch
- Understand manufacturing capabilities and capacity of the organization
- Understand manufacturing and engineering processes that relate to the medical device industry
- Support estimating efforts for company products and services
- Lead discussions with customers and internal teams on designs, troubleshooting and finding cost-effective solutions
- Manage/facilitate transfers to production
- Communicate with customers on a routine basis and provides project plans, timelines, and milestones
- Proactively recommends, promotes, and supports actions for implementing continuous improvement projects. Assists internal teams with cost reductions, root cause analysis, and corrective actions
- Work closely with Engineering, Operations/Production, Supply Chain, Scheduling, and Quality to meet or beat customer delivery dates and On-Time-Delivery (OTD) performance
- Work with Quality to facilitate customer required audits
- Supports S&OP planning for assigned programs and customers
Qualifications
Program Manager Requirements:
- Associates Degree in related field
- 4 years of experience in contract manufacturing and/or engineering role
- Extensive experience with medical device contract manufacturing
- Experience managing numerous projects simultaneously using appropriate software tools (i.e. Excel or Microsoft Project) and professionally communicating project status to customers
- Understanding of Laser Processing and Assembly
- Knowledge of ISO 13485, and FDA regulations
- Complete understanding of MRP and DFM principles
- Experience with the CAPA system
- Ability to consistently achieve short and long-term business results
- Experience with root cause analysis, corrective actions, and preventative action
- Knowledge and experience with Lean Manufacturing
- Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint)
Program Manager Preferred Requirements:
- Bachelor's Degree in Engineering
- PMP Certification
What is it like to work at Cretex Medical?
We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement.
Here are some of things that employees have aid about working for Cretex Medical:
- "The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right."
- "I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it."
- "I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives."
We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member.
Company Benefits:
Cretex Medical offers a full benefit package to its employees. Benefits include medical, dental, vision and life insurance options. Cretex Medical also offers a 401(k)-retirement plan with employer match, profit sharing, short- and long-term disability insurance, paid time off and holiday pay.
Cretex Medical also offers company-specific benefits, such as:
- Employee Appreciation events
- Volunteer Opportunities
- Training and Development opportunities
- Tuition Reimbursement
- New state-of-the-art facility in Brooklyn Park!
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.