Senior Engineer, Quality Manufacturing (Second Shift)

Responsibilities

• Provide on-the-floor quality engineering support to production teams, ensuring real-time issue resolution.
• Develop, review, and approve inspection and test plans, sampling methods, and control plans.
• Process Improvement: Continuously identify and implement process improvements to enhance product quality, reduce waste, and optimize manufacturing efficiency.
• Risk Assessment: Conduct risk assessments related to manufacturing processes and identify potential areas for risk mitigation to ensure the safety and efficacy of medical devices.
• Regulatory Compliance: Stay up to date with regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that manufacturing processes adhere to these regulations.
• Supplier Collaboration: Work closely with suppliers to assess and improve the quality of incoming components and materials, fostering strong supplier relationships.
• Root Cause Analysis: Investigate and resolve quality issues by performing root cause analysis and implementing corrective and preventive actions.
• Documentation: Maintain accurate and complete documentation of quality-related processes, inspections, and testing, ensuring compliance with Good Manufacturing Practices (GMP).
• Training: Provide training to manufacturing personnel on quality-related procedures, standards, and best practices.
• Audit Support: Support internal and external audits, including FDA inspections, by providing documentation, data, and expertise related to manufacturing quality.
• Product Testing: Support and coordinate product testing, equipment qualifications, validation and verification processes to ensure required specifications are met.
• Mentor and provide technical guidance to junior engineers, fostering their professional growth and development within the organization.
• Participate in the creation and execution of intellectual property strategies, including the drafting and filing of patent applications.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related Engineering field.
• 5+ years in medical device production development.
• Previous experience working in a cleanroom environment is highly preferred.
• Preferred certifications: ASQ Certified Quality Engineer (CQE), Six Sigma Green/Black Belt.
• Strong engineering and quality background with basic knowledge of statistics/use of Minitab.
• Strong communication skills.
• Ability to make independent decisions (proactive, detail-oriented, and solution-driven).
• Fluent in English.
• Light office work and telecommuting capability.
• Available to travel 20% of the time, as required domestic and international.
• Must be able to lift and carry up to 50 lbs.

Pay / Compensation

The expected pre-tax pay rate for this position is $94,600 - $127,600 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location. US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.