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.

Your role

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.

Your role

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.

Project Engineer

Project Engineer

Röchling Medical

Röchling Medical

Benefits

Röchling Medical