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