Project Manager

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

Benefits offered by this job

401(k)

Flexible spending account

Health insurance

Life insurance

Paid time off

Vision insurance

Job summary

Röchling Medical in Rochester, NY seeks a seasoned Project Manager in manufacturing to ensure on-time delivery, quality and budget adherence across multiple teams. You will coordinate scope, develop plans, manage customer communications, and lead risk mitigation to keep programs on track.

You'll collaborate with Sales, QA, Document Control and suppliers, review routings and BOMs, and drive process improvements through the Product Realization Process to meet manufacturing goals and profitability.

Qualifications

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

Responsibilities

• Coordinate project plans to meet milestones, timelines, and budget.
• Communicate with internal/external teams on scope, plan, tasks, timeline, status, and budget.
• Act as primary liaison with customers and manage escalations.
• Manage scope creep and adjust work plans as needed.
• Identify and mitigate project risks, budget, and schedule.
• Track project expenses and ensure timely invoicing to customers.
• Lead Product Realization Process with QA, Document Control and Quality Assurance.
• Provide engineering support to other departments as needed.
• Collaborate with Sales to define project details for proposals and quotes.
• Review routings and BOMs as needed.
• Coordinate with outsource suppliers and maintain records.
• Provide other project management support as requested.

Skills

Project management

Customer liaison

Budget management

Risk management

Education

Bachelor's degree

Engineering preferred

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

• 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.
• Experience with quality system documentation practices
• Knowledge of ISO, AS9100 and FDA concepts and guidelines

Pay

$90,000.00 - $120,000.00 per year

Job Type: Full-time

• 401(k)
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

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.