Program Manager

Cretex Medical Component and Device Technologies

$100K — $151K *
Healthcare
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Associates Degree in a related field
  • 4 years of experience in contract manufacturing and/or engineering
  • Extensive experience with medical device contract manufacturing
  • Ability to manage multiple projects using software tools (e.g., Excel, Microsoft Project)
  • Understanding of Laser Processing and Assembly
  • Knowledge of ISO 13485 and FDA regulations
  • Experience with the CAPA system

Responsibilities

  • Administer customer projects through the new product engineering stage gate process
  • Ensure compliance with the company Quality Management System and regulatory standards
  • Build and maintain positive relationships with internal and external customers
  • Direct the NPI cross-functional team and facilitate teamwork
  • Create project plans/timelines to ensure successful commercial launches
  • Support engineering and manufacturing in achieving customer delivery dates
  • Facilitate continuous improvement projects and assist with cost reductions

Benefits

  • 401k retirement savings plan with company match
  • Onsite health clinics and wellness program
  • Access to 24/7 employee assistance program
  • Comprehensive medical insurance with virtual provider access
  • Dental and vision insurance
  • Paid time off and holidays
  • Tuition assistance programs for eligible employees
Full Job Description
Overview

Position 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


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.)

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