Project Engineer (Rochester)

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 :

Bachelors 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.

Physical Requirements :

Prolonged periods of sitting at a desk and working on a computer.

Must be able to lift up to 30 pounds at times.

Work Environment :

Manufacturing environment requiring appropriate eye protection.

Exposure to high noise level in the work environment requiring hearing protection.

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.