Principal Process Engineer

Otsuka Pharmaceutical Co., Ltd; Palo Alto (CA); On-site; USD 155,000 - 189,000; Full time

Job summary

An established industry player is seeking a Principal Process Engineer to lead the advancement of commercial controls for innovative medical devices. This hands-on role focuses on ensuring product quality and operational efficiency while driving data-driven decisions. You will manage control programs, collaborate with engineering teams, and oversee new product introduction deliverables, all while maintaining compliance with strict FDA and ISO regulations. Join a pioneering team dedicated to transforming hypertension treatment and making a meaningful impact on patients' lives worldwide. If you are a proactive leader with extensive experience in regulated environments, this is the perfect opportunity for you.

Qualifications

• 10+ years in regulated environments like medical devices.
• Strong background in statistics and project management.

Responsibilities

• Manage design and implementation of control programs.
• Collaborate with engineering for control improvements.
• Ensure compliance with FDA and ISO regulations.

Skills

Statistical Analysis

Project Management

Communication Skills

Multi-tasking

Education

BS in Mechanical Engineering

BS in Electrical Engineering

BS in Biomedical Engineering

BS in Process Engineering

Tools

MES systems

Statistical Process Control (SPC)

Job description

Principal Process Engineer page is loaded

Principal Process Engineer

Apply remote type Onsite locations Palo Alto time type Full time posted on Posted 7 Days Ago job requisition id R8912

At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.

Position Summary

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.

Responsibilities including but not limited to:
• 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

Requirements:
• 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
• 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

Salary Range: $155,081- $188,753 (Annual Base Salary)

The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions.

Equal Employment Opportunity
At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

Respecting your privacy is an essential part of the Company’s privacy program and we are committed to the proper handling of Personal Information collected or processed in connection with an Applicant’s application for employment, a Contract Worker’s work, or a Former Employee’s employment at Recor. Refer to our Applicant, Contract Worker & Former Employee Privacy Policy for more detail information.