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.
• Manage a few discrete projects with teams, operating within a defined PDP process delivering to achieve defined scope, schedule, and budget performance goals.
• 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.
• Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.
• 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.
• 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.

Benefits

• 401K Match: Save for retirement with the company's help.
• Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.
• Sustainability & Social Commitment: We support social and sustainable projects and encourage employee involvement.
• Personal Development: We offer a variety of trainings to ensure you can develop in your career.
• Corporate Events: We celebrate success as a team, because only together can we achieve our goals.

Pay

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

Schedule

On-Site Freudenberg Medical LLC payments