Program Manager

Cretex Companies, Inc.; Dassel (MN); On-site; USD 101,000 - 151,000; Full time

Benefits offered by this job

401k with company match

Onsite health clinics

Employee wellness program

Job summary

Cretex Medical is seeking a Program Manager to support the Laser Processing business unit, driving engineering projects from prototyping to production and serving as a customer advocate. You may supervise staff and will ensure adherence to quality and regulatory standards across development cycles.

The role requires coordinating multi-department teams, creating plans, and maintaining strong customer relations to enable timely, cost-effective launches in a medical device environment.

Qualifications

• 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)

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

Skills

Project management

Customer liaison

Leadership

Lean manufacturing

Education

Associates Degree in related field

Bachelor’s Degree in Engineering

PMP Certification

Experience with ISO 13485 and FDA regulations

Tools

Microsoft Project

Excel

MS Office

Job description

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 .

Overview

About 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 .

P Osition Summary

The Program Manager will support the Laser Processing business unit, and will be responsible for facilitating all aspects of the engineering projects for assigned customers from the early prototyping stage all the way into a production program. This position acts as the customer advocate and leads customer programs that ensures compliance to customer, industry, and company requirements and standards. This position may supervise employees.

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 said 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.

Pay Range

USD $100,900.00 - USD $151,300.00 /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 .