Global Medical Device Program Lead (Remote-Ready)

Röchling Medical; Lancaster (CA); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Health Management

Training and Development

Food

Flexibility

Job summary

Röchling Medical is seeking an experienced Senior Project Manager to lead strategic customer programs across our global sites. You will coordinate cross-functional teams across engineering, quality, regulatory, and supply chain to drive development, design transfer, validation, and manufacturing readiness.

You will manage scope, risks, and budgets while ensuring timely decisions, customer communications, and evidence for gate reviews.

Qualifications

• Bachelor's degree in engineering or related technical field.
• 10+ years of progressive project management experience leading complex medical device programs.
• Experience with metal-plastic assemblies and electromechanical devices.
• Familiarity with FDA requirements, ISO 13485/14971 and design controls.

Responsibilities

• Create integrated project plans covering scope, deliverables, resources, schedule, budget, risks, decisions, and status.
• Lead gated governance from opportunity assessment through commercialization.
• Serve as primary customer interface across technical, quality, regulatory, commercial and supply-chain workstreams.
• Lead product realization from customer requirements through design transfer and manufacturing release.

Skills

Project leadership

Cross-functional collaboration

Risk management

Budget management

Stakeholder management

Education

Bachelor's degree in engineering

10+ years PM experience

Tools

MS Project

SolidWorks

Minitab

Job description

Röchling Medical is seeking an experienced Senior Project Manager to lead strategic customer programs across our global sites. You will coordinate cross-functional teams across engineering, quality, regulatory, and supply chain to drive development, design transfer, validation, and manufacturing readiness.

You will manage scope, risks, and budgets while ensuring timely decisions, customer communications, and evidence for gate reviews.