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Project Manager

Freudenberg Medical LLC -
Minnetonka, MN

Apply Now

Job Details

$85,000 - $115,000 a year

Benefits

401(k) matching

Qualifications

Project reporting
ISO 14001
Project development phase management
Budget control
Six Sigma methodology implementation
GMP
Schedule management
Managing engineering teams
Medical device manufacturing facility experience
Engineering project budget management
Leading team collaboration initiatives
Regulatory/legal compliance standards in production
Quality standards in production
Biomedical regulatory compliance
Managing projects
Quality improvement programs in engineering
Environmental management systems
FDA regulations

Full Job Description

Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.

Some of your Benefits

401K Match

401K Match: Save for retirement with the company's help.

Diversity & Inclusion

Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.

Sustainability & Social Commitment

Sustainability & Social Commitment: We support social and sustainable projects and encourage employee involvement.

Personal Development

Personal Development: We offer a variety of trainings to ensure you can develop in your career.

Corporate Events

Corporate Events: We celebrate success as a team, because only together can we achieve our goals.

*Candidates must be legally authorized to work in the United States without current or future visa sponsorship*

Minnetonka, MN

Jeffersonville, IN

On-Site

Freudenberg Medical LLC

payments The expected salary range for this position is $85,000 to $115,000annually, depending on skills, experience, and qualifications

You support our team as

Project Manager

Responsibilities

Lead development of accurate manufacturing cost models, make-vs-buy decisions, work-center costs, and support quote generation and pricing strategy for new business or large sustaining initiatives.
Establish, track, and report key performance metrics for development, project progression, and launch; champion continuous-improvement and Lean/Six Sigma activities to boost quality, delivery, and cost.
Gather and translate user, customer, clinician, and/or market needs and inputs into clear product and business requirements; present data-driven recommendations to stakeholders.
Maintain project documentation in line with internal procedures and notified-body expectations, supporting audits and ensuring robust change-control and traceability. Prepare reports and project summaries to communicate the status of projects on a regular basis.
Provide technical and project-management leadership, set priorities, allocate tasks, mentor team members, and foster a culture of efficiency, innovation, and regulatory excellence across the organization.
Manages a few discrete projects with teams, operating within a defined PDP process delivering to achieve defined scope, schedule, and budget performance goals.
Familiarity with and managing efforts for compliance with ISO standards, country-specific (FDA, MDR, Health Canada, PMDA, etc.), GMP regulations, and customer requirements.
Input and review for design history files, device master records, risk analyses, and validation protocols/reports (IQ/OQ/PQ) to ensure designs, processes, equipment, and products meet client, regulatory, and business needs.

Qualifications

Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.
3+ years’ experience in Medical Device or related industry
2+ years’ experience in leading teams in a manufacturing or engineering environment, with demonstrated experience of managing work within a project plan framework, including managing a schedule, budget, scope, progress, and reporting.
Understanding of scientific principles and manufacturing processes used in medical device production, such as running equipment, injection molding, extrusion, catheter manufacturing, and assembly, including the materials used.
Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.
Understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971, and 45001. Knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements (i.e., 21 CFR 820 in the United States, and EU MDR).
Demonstrated experience using Lean/Six Sigma tools as necessary for new and continuous improvement projects.
Demonstrated experience providing leadership and managing multiple projects of low to medium complexity.

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. #LI-MEDICAL

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