Sr. Manufacturing Engineer

ZipRecruiter; Menlo Park (CA); Hybrid; USD 145,000 - 196,000; Full time

Job summary

An established industry player is seeking a Sr. Manufacturing Engineer to lead the development and production of innovative ophthalmic medical devices. This role involves collaborating with R&D teams, managing external manufacturers, and implementing lean principles to enhance production efficiency. The ideal candidate will have a strong background in biomedical or mechanical engineering, with at least five years of experience in the medical device sector. Join a dynamic team where your contributions will drive the success of cutting-edge products and improve patient outcomes.

Qualifications

• 5+ years in medical device industry with product introduction experience.
• Ability to create manufacturing documentation including MPIs and BOM.

Responsibilities

• Collaborate with R&D to define manufacturing requirements for new products.
• Manage external manufacturing teams to ensure high-quality production.

Skills

Biomedical Engineering

Mechanical Engineering

Lean Manufacturing

Continuous Improvement

Process Validation

Risk Management

Design Control

Communication Skills

CAD Proficiency

GMP Knowledge

Education

Engineering Degree

Tools

SolidWorks

MS Project

Statistical Software

Excel

PowerPoint

Word

Job description

Overview:

The Sr. Manufacturing Engineer is responsible for introducing and supporting the manufacturing of products that serve the company's commercial objectives. This role includes leading transfers to manufacturing of new product introductions, line extensions, and sustaining engineering responsibilities. The individual will work with internal teams and external contract manufacturing partners to achieve efficient, high-quality production conforming to industry and company standards. The Sr. Manufacturing Engineer plays a key role in the development, launch, and sustained production of market-leading ophthalmic medical device products.

Responsibilities:

• Collaborate with R&D and other functions to define manufacturing requirements and enable processing capabilities for new product introductions.
• Develop, transfer, and mature processes supporting robust, high-volume manufacturing using lean principles and continuous improvement.
• Implement design and process improvements, providing innovative solutions for product enhancements, cost reduction, and scaling production, ensuring high quality and low complaint rates.
• Manage external manufacturing teams with clear responsibilities, controls, and timelines.
• Support Quality initiatives with QMS improvements and risk-driven change management.
• Develop test methods and protocols, conduct DOEs, and analyze data to inform decisions.
• Establish relationships with new suppliers to improve performance, cost, or quality; participate in supplier selection and CAPA efforts.
• Develop fixtures or equipment to reduce risks and optimize production.
• Create detailed component and assembly drawings to meet design specifications.
• Address customer feedback to enhance commercial performance.
• Contribute to the company's intellectual property portfolio.
• Maintain awareness of technological, medical, and biomedical developments relevant to the company.
• Ensure compliance with FDA QSR, ISO 13485, and other applicable regulations.
• Promote team building and morale within the department.
• Perform all duties in accordance with company policies, procedures, and legal requirements.

Skills/Qualifications:

• Engineering degree in biomedical, mechanical, engineering, or equivalent experience.
• At least 5 years of related experience in the medical device industry.
• Experience in market introduction of new products.
• Supporting external high-volume medical device production experience, including electronic HW/SW and single-use devices.
• Ability to create and update manufacturing documentation (MPIs, LHR, BOM, flowcharts, etc.).
• Knowledge of DFM, injection molding, tolerance analysis, and fabrication processes.
• Experience with process validation, GMP, and advanced manufacturing techniques.
• Lean manufacturing and continuous improvement expertise.
• Strong understanding of risk management and design control in medical devices.
• Familiarity with regulatory requirements and guidance.
• Experience with both pre-commercial and commercial manufacturing.
• Proficiency in CAD, prototyping, and testing.
• Sound decision-making and judgment skills for a senior role.
• Excellent communication skills.
• Proficiency in Word, Excel, SolidWorks, PowerPoint; MS Project and statistical software are advantageous.
• Self-motivated and proactive.
• Willingness for low to medium travel.

#LI-Hybrid

For California, the salary range is $145,000-$196,000 annually, with competitive, performance-based compensation.