Program Manager

Röchling Medical; Rochester (MN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health benefits

Training programs

Snack options

Flexible/mobile work

Job summary

Röchling Medical Rochester is seeking a seasoned Project Manager to lead manufacturing projects from conception through execution. You will coordinate with internal teams and customers to ensure on-time delivery while maintaining quality and budget controls.

The role requires 5 years of PM experience in manufacturing (medical device preferred), a Bachelor’s degree, and familiarity with ISO/AS9100/FDA processes.

Qualifications

• 5 years of Project Management in a manufacturing environment; Medical Device preferred.
• Bachelor’s degree (or equivalent years of experience) required; Engineering preferred.
• PMP certification a plus.
• Experience with quality system documentation practices.
• Knowledge of ISO, AS9100 and FDA concepts and guidelines.

Responsibilities

• Own and ensure project milestones, deliverables, timelines, and budgets are met.
• Develop and execute project plans; communicate status regularly with internal/external teams.
• Act as primary coordinator with customers to resolve issues and follow up on concerns.
• Manage scope creep and revise project plans as needed to meet changing requirements.
• Coordinate with Quality Control, Document Control and QA for Product Realization; ensure manufacturing goals are met.

Skills

Project management

Cross-functional coordination

Communication with customers

Risk management

Quality system knowledge

Education

Bachelor’s degree in Engineering or related field

PMP certification

Experience with ISO/AS9100/FDA concepts

Tools

ERP systems

Job description

At Röchling Medical, we’re united by a shared purpose: improving lives through innovation in health. As a trusted partner to leading pharmaceutical, biotech, and medical device companies around the world, we develop customized products and solutions that help advance patient care and save lives.

Your role

Essential Duties/Responsibilities:

• Responsible & accountable for project completion ensuring timelines, deliverables and quality standards are met.
• Ensure project scope is clear. Develop and execute a project plan to meet defined milestone and deadline deliverables; communicate regularly with internal/external teams: scope, plan, tasks, timeline, status, and budget.
• Act as primary coordinator/communicator with customers. Resolve project issues, manage escalation and ensure timely follow-up on customer concerns.
• Manage scope creep. Create and execute project work plans and revisions as appropriate to meet changing needs and requirements.
• Identify and mitigate project/business risks, appropriately correct course of action, budget, and schedule.
• Manage project expenses/hours and ensure timely invoices to customers.
• Lead and manage Product Realization Process to move products into manufacturing assuring accurate and thorough input by internal stakeholders. This includes planning efforts for new projects in conjunction with Quality Control, Document Control and Quality Assurance areas (e.g., FMEA, Measurement Systems Analysis, SPC & PPAP). Ensure manufacturing goals per the quote are met to sustain long-term profitability of the project - e.g., cycle time / labor.
• Serve as technical, engineering or backup resource in additional departments as needed. Identify or lead efforts to identify opportunities for productivity and quality improvements.
• Collaborate with sales team to define realistic project details to support an accurate proposal and quoting process.
• Prepare/update and/or review routings & bill of materials (BOM) as needed.
• Examines documents, such as blueprints, drawings, change orders, and specifications to verify completeness and accuracy of data.
• Ensure communication with outsource components or equipment suppliers.
• Compiles and maintains control records and related files.
• Provide other engineering and project management support as requested by immediate supervisor.

Education and Experience:

• 5 years of Project Management in a manufacturing environment required, Medical Device preferred.
• Machining and contract manufacturing experience preferred.
• Bachelor’s degree (or equivalent years of experience) required; Engineering preferred.
• PMP (Project Management Professional) certification a plus
• Experience with quality system documentation practices
• Knowledge of ISO, AS9100 and FDA concepts and guidelines

Roechling Medical Rochester (RMR) is an Equal Opportunity Employer. RMR does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Your benefits

• Health Management: Your health and well-being are important to us. Take advantage of our diverse health offerings, such as the health clinic.

• Training and Development: Our focus is on the continuous growth of our team members. We want to ensure that everyone can reach their full potential, which is why we offer tailored training programs for various roles. This helps you achieve peak performance and boosts your professional success!

• Food: Our sites offer vending machines with a variety of snacks and food options for you to enjoy - perfect for added flexibility during shift work, ensuring convenient access to refreshments at any time.

• Flexibility: Flexibility leads to efficiency – that’s what we believe. That’s why mobile work is possible.