Job Summary:
A leading medical device organization is seeking a Manufacturing Engineer II to support manufacturing operations for Class III medical devices. This role will focus on process validation, risk assessment, process controls, supplier changes, and cross-functional project execution. The ideal candidate will bring strong manufacturing engineering experience within a regulated medical device environment and the ability to manage multiple projects simultaneously.

Key Responsibilities:

• Lead and support complex manufacturing engineering initiatives within a regulated Class III medical device environment.
• Develop, implement, and improve manufacturing processes to support product quality, efficiency, and compliance.
• Execute and support process validation activities including IQ, OQ, and PQ protocols.
• Conduct risk assessments and implement appropriate process controls to mitigate manufacturing risks.
• Collaborate with internal and external stakeholders to resolve manufacturing and process-related challenges.
• Manage supplier-related changes and assess their impact on manufacturing operations.
• Drive project timelines and coordinate activities across cross-functional teams.
• Analyze manufacturing performance and recommend process improvements using industry-standard methodologies.
• Support verification and validation activities while ensuring compliance with quality and regulatory requirements.
• Participate in continuous improvement initiatives utilizing Lean, Six Sigma, GMP, and related manufacturing methodologies.
  
  Required Qualifications:
• Bachelor of Science or Bachelor of Engineering in Mechanical Engineering, Electrical Engineering, Software Engineering, or a related engineering discipline.
• Minimum 5 years of manufacturing engineering experience supporting Class III medical devices.
• Strong knowledge of process validation methodologies including IQ, OQ, and PQ.
• Experience with risk assessment, process controls, and manufacturing process development.
• Experience working with internal and external stakeholders in a regulated environment.
• Proven ability to manage project timelines and support multiple concurrent projects.
• Experience collaborating with cross-functional teams including quality, operations, supply chain, and engineering.
• Knowledge of Lean Manufacturing, Six Sigma, GMP, and continuous improvement principles.
  
  Preferred Qualifications:
• Experience supporting catheter manufacturing processes.
• Prior experience within a highly regulated medical device manufacturing environment.
• Experience managing supplier change control activities.
• Knowledge of manufacturing verification and validation requirements.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.

Pay Range: $30/hr to $38/hr

If interested, you can also share your resume at gagandeep.singh@collabera.com