Principal Process Engineer

Recor Medical; Palo Alto (CA); On-site; USD 155,000 - 188,000; Full time

Job summary

Recor Medical is seeking a Principal Process Engineer to lead the advancement of commercial controls and readiness for suppliers and manufacturing, ensuring product quality and operational efficiency. This hands-on role requires expertise in engineering disciplines and significant experience in regulated environments, particularly within the medical device industry. Candidates will engage with various operational aspects, from supply chain to manufacturing control, to support data-driven decisions and maintain compliance with industry regulations.

Benefits

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Disability insurance

Qualifications

• 10+ years of experience in a regulated environment (medical devices).
• Hands-on leadership; experience in managing control programs necessary.

Responsibilities

• Manage design and implementation of control programs for Operations and suppliers.
• Develop and maintain process monitoring plan; perform statistical control evaluations.

Skills

Statistics

Communication

Organization

Multi-tasking

Education

BS in Mechanical Engineering

BS in Electrical Engineering

BS in Biomedical Engineering

BS in Process Engineering

Tools

MES system

Job description

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This range is provided by Recor Medical. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$155,000.00/yr - $188,000.00/yr

Additional compensation types

Annual Bonus

About the Role

This is a hands-on position which will lead the advancement of commercial controls and readiness activities for Recor suppliers and manufacturing to ensure product quality, operational efficiency, and support data-driven decisions.

This role involves managing the design and implementation of control programs for Operations, including facilities, supply chain, manufacturing, and external suppliers, as needed.

Responsibilities

• Manage the design and implementation of control programs for Operations, including facilities, supply chain, manufacturing, and external suppliers, as needed
• Development and maintenance of process monitoring plan (including supplier processes)
• Statistical Process Control (SPC) creation, monitoring, and response to SPC events; able to drive root cause assessments and corrective actions efficiently and effectively
• Ensuring strong supplier controls including driving process characterizations, supporting process validations, and reviewing and providing input in process instructions
• Manage the support of sustaining engineering objectives, including:
• Collaborating with Production/Manufacturing Engineering to assess potential control methods/ recommendations for control improvements
• Building quality into processes via specifications/work instructions
• Test method validations
• Maintaining process risk documentation as well as drive updates to suppliers’ risk documentation, as necessary
• Determining qualification requirements for second suppliers / process updates
• Participation in definition and configuration of electronic manufacturing support software such as LHR, MES systems, barcoding
• Manage the completion New Product Introduction deliverables, such as:
• Test Method alignment with suppliers
• Master Validation Plan development and maintenance
• Manufacturing control: review / update traveler, ensure supporting documents are appropriate for guiding manufacture
• Monitor training effectiveness and implement training standards for manufacturing
• Identify and seek feedback from other functions to develop scalable and efficient control solutions
• Must execute work in a manner compliant with FDA and ISO regulations for medical device development and manufacture
• Must be a cooperative, engaged, hands-on leader

Qualifications

• BS in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Process Engineering, or related technical discipline
• Must have 10+ years of experience in a regulated environment such as medical devices

Required Skills

• MES system experience preferred
• Both capital equipment and disposable experience preferred
• Must have a strong background in statistics
• Must have the ability to multi-task in a fast-paced environment and respond to changing priorities
• Excellent communication and organization skills

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering, Manufacturing, and Product Management

• Industries

  Medical Equipment Manufacturing and Biotechnology Research

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Disability insurance

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