Project Engineer

Röchling Medical•Rochester, MN

1d•Hybrid

About The Position

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. With over 1,300 team members across six locations in Europe, North America, and Asia, we bring together a diverse range of expertise in plastics and metalworking to support critical applications in pharmaceuticals, diagnostics, and medical technology. What drives us? A deep passion for health – and a belief that meaningful work happens when everyone’s contribution matters. Joining our team means shaping the future of healthcare with purpose, collaboration, and a commitment to making a difference.

Requirements

Excellent verbal and written communication skills.
Excellent problem-solving, analytical, and organizational skills.
3+ years of experience in project engineering or a similar role within the medical device or related manufacturing industry.
Strong understanding of manufacturing processes and equipment used in medical device production.
Strong communication and collaboration abilities, with experience working in cross-functional teams.
Advanced MS Office skills
Familiarity with rules, regulations, best practices and performance standards
Decision making ability and leadership skills
Knowledge of regulatory requirements and quality standards (ex: ISO13485, FDA)
Bachelor’s degree in mechanical or industrial engineering or equivalent.
Experience developing manufacturing processes for medical devices.

Nice To Haves

Experience with Lean Manufacturing, Six Sigma, or similar continuous improvement methodologies.
Familiarity with validation and verification processes (e.g., IQ, OQ, PQ).
Project Management Professional (PMP) certification.
Hands-on experience with automation and advanced manufacturing technologies.
Demonstrated track record of successful project delivery in a fast-paced, regulated environment.
Preferred experience with injection molding, small part assembly, welding, robotics, automation, vision systems, and pad printing.

Responsibilities

Support the design and validation of manufacturing processes, tools, and equipment for medical device production.
Collaborate with cross-functional teams to resolve technical issues and optimize processes for quality and efficiency.
Ensure compliance with applicable regulatory standards (e.g., FDA, ISO 13485) throughout project lifecycles.
Conduct risk assessments and develop mitigation strategies for design and production phases.
Prepare and maintain technical documentation, including engineering drawings, specifications, and reports.
Analyze data and implement continuous improvement initiatives to enhance product performance and reduce costs.
Serve as a liaison between engineering, manufacturing, and quality teams to ensure project alignment and successful execution.