Senior Manufacturing Engineer

Otsuka Pharmaceutical Co., Ltd; Palo Alto (CA); On-site; USD 138,375 - 145,000; Full time

Job summary

Recor Medical is looking for a professional to lead labeling operations, ensuring compliance and efficiency in a regulated environment. You will collaborate closely with production teams and regulatory affairs to drive product quality and adherence to specifications.

The ideal candidate holds a Bachelor of Science degree in Engineering and has at least 5 years of experience in medical device regulatory labeling. Strong collaboration skills and proficiency in statistical analysis tools are essential. Join us in making an impact on patients' lives with innovative solutions.

Qualifications

• Minimum of 5 years in a regulated medical device industry.
• Experience in global regulatory labeling and packaging.
• Proficiency with ERP systems and electronic label management.

Responsibilities

• Collaborate with Production teams for engineering support.
• Lead labeling content development and lifecycle management.
• Align with Regulatory Affairs on packaging activities.

Skills

Regulatory labeling and packaging

Collaboration with manufacturers and suppliers

Statistical analysis tools

CAD experience

Lean or Six Sigma experience

Education

Bachelor of Science in Engineering

Tools

ArtiosCAD

Adobe Illustrator

SolidWorks

JMP

MiniTab

Job description

Position Summary

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.

Responsibilities and Duties

• Collaborate closely with Production teams to provide sustaining engineering support, resolving product and process issues within a controlled cleanroom environment.
• Lead the development and lifecycle management of labeling content, including product labels, packaging labels, Instructions for Use (IFUs), inserts, and digital labeling.
• Ensure alignment with product design outputs and compliance with change control processes.
• Own the end-to-end labeling process—from concept development and artwork creation to print proofing, verification, and final release—utilizing tools such as ArtiosCAD, Adobe Illustrator, or equivalent platforms.
• Collaborate closely with Regulatory Affairs on packaging and labeling activities supporting regulatory submissions, product registrations, and global market expansion.
• Identify and drive production capacity improvements.
• Participate as an extended team member for new product introduction, including scaling up, stabilizing and transfer to alternate sites.
• Hands on development, qualification and implementation of new production systems integrating mechanics, electronics, and software.
• Identify, manage, and qualify alternate supply sources or new vendors.
• Hands on investigation and root cause analysis.

Requirements

• Bachelor of Science degree in Engineering or related field with a minimum of 5 years in a regulated environment such as the medical device industry.
• 5 years of experience in global regulatory labeling and packaging requirements, including experience supporting new product introductions and implementing labeling updates across global markets.
• Proficiency with ERP systems and electronic label/UDI management tools.
• Experience with disposable devices (Class II / III), preferably balloon catheters and sterile packaging.
• Strong collaboration skills with contract manufacturers and suppliers that include aligning goals, managing expectations, and ensuring adherence to specifications and timelines.
• Working knowledge of injection molded plastic components is a plus.
• Proficiency with statistical analysis tools (JMP, MiniTab).
• CAD experience (SolidWorks preferred).
• Self-motivated, action oriented and result oriented.
• Deep understanding of medical device processes and assembly knowledge to drive product yield and performance.
• Lean or Six Sigma experience (Green Belt a plus).

Salary

Salary range: $138,375 - $145,000 (Commensurate with experience, skills, education and training) 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.