Program Manager

Cretex Medical Component and Device Technologies•Dassel, MN

24d•$100,900 - $151,300•Onsite

About The Position

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.

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)

Nice To Haves

Bachelor’s Degree in Engineering
PMP Certification

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

Benefits

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
Employee death benefit
Employee sick and safe leave
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
Pre-tax health savings account
Healthcare and dependent care pre-tax reimbursement accounts
Paid holidays
Paid time off
Discretionary profit sharing program
Parental Leave
Accident and critical illness benefits
Optional employee, spouse, and child life
Short and long term disability
Company provided life insurance
Tuition assistance programs