Project Manager

About the role

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.

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.

Requirements

• 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.

Pay

$90,000.00 - $120,000.00 per year

Schedule

Full-time, in person

Benefits

• 401(k)
• Dental insurance
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance