Project Engineer

5 days ago

Rochester, United States Röchling Medical Full time

Roechling Medical Rochester offers customers a wide range of high-quality, customized components and assemblies, right through to end-to-end OEM products. The product portfolio also includes standard plastic products, with special expertise in the fields of diagnostics, fluid management, pharma, surgery and interventional, and much more. These areas of competence are complemented by an enhanced range of services for development and regulatory affairs, right through to approval of end-to-end medical products.


Job Summary:

The Project Engineer is responsible for managing and supporting the design, development, and implementation of projects to ensure successful delivery, quality assurance, and regulatory compliance. This position involves close collaboration with cross-functional teams, including design, tooling, production, quality, and regulatory departments, to drive innovative solutions and optimize manufacturing processes.

Essential Duties/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.

Required Skills/Abilities:

·       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)


Desired Qualifications:

·       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.


Education and Experience:

Bachelor’s degree in mechanical or industrial Engineering degree or equivalent.

Experience developing manufacturing processes for medical devices. Preferred experience with injection molding, small part assembly, welding, robotics, automation, vision systems, and pad printing.


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.

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