Sr. Manufacturing Engineer

Route 92 Medical Inc • San Mateo, CA

10d

About The Position

Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention. At the core is a reconsidered procedural approach, cutting-edge engineering, and innovative product design. Our portfolio targets the most significant challenges in neurointerventional care to deliver meaningful solutions. The company was founded by physicians developing thoughtful product solutions in collaboration with the world’s leading clinicians, who focus on improving procedural and patient outcomes. Route 92 Medical is looking for dynamic, innovative people who are inspired by our mission to improve outcomes for patients undergoing neurovascular intervention. We welcome team members who approach their work with courage, flexibility, persistence, and a willingness to assist others. Teamwork matters here. We are committed to collaboration and finding innovative solutions that advance neurovascular intervention, establishing Route 92 Medical as one of the premier companies in the field. PURPOSE OF JOB: To lead transfer activities for new products and processes to meet corporate growth objectives. To develop process capabilities and production capacity to provide readiness to scale for commercial launch. To provide manufacturing support for existing products and processes to meet company goals.

Requirements

• Adaptable to a fast-paced environment
• Effective communication, cross-functional team, interpersonal, and time management skills required.
• Proficiency with MS Office, SolidWorks, Project Management, and Minitab applications preferred
• Required ability to travel up to 15% to West Jordan, UT (a few days a quarter)
• Bachelor’s Degree in Engineering, Materials, or Science required.
• Minimum of 5 years of experience preferably in the regulated Medical Device or Aerospace industry.

Nice To Haves

• Advanced degrees (MS/MBA) desirable.
• Knowledge of industry standard processes for assembly, coating, and packaging of catheter systems.
• Proven project management experience contributing as either team leader, team member, or contributor.
• Excellent communication, cross-functional team, interpersonal, and time management skills required.
• Training/certifications in Lean/Six-Sigma, Project Management, Statistics, and CAD tools desirable.

Responsibilities

• Lead pilot/engineering build activities for product or process enhancements.
• Work cross-functionally with product development to ensure products are developed with considerations for manufacturability and scalability for volume manufacturing.
• Design and develop manufacturing processes for new and existing products, product changes, and related tooling and fixture modifications.
• Perform or guide validations on equipment and processes (IQ/OQ/PQ) as well as creating test protocols in collaboration with Quality and preparing reports.
• Prepare document change orders and coordinates implementation of changes, including training operation team members.
• Improve manufacturing process instructions and lot history records, line flow, assembly methods, and product quality; assure manufacturing processes and related documentation follow established policies and procedures.
• Creates and modifies component, assembly, or fixture drawings using SolidWorks.
• Provides line support, trouble-shooting, and coordinating repair of equipment.
• Ensure reliability and performance of process equipment to deliver product to desired specifications.
• Support company goals and objectives, policies and procedures while adhering to Good Manufacturing Practices, quality system requirements, and FDA regulations.

Benefits

• Comprehensive healthcare benefits are effective day one! R92M offers generous benefit options, including Medical, Dental, Vision, Life Insurance, FSA, HSA, Short-term and Long-term disability, Critical Illness Insurance, and Accident Insurance.
• Competitive base pay plus corporate bonus program
• Generous paid time off and 16 paid holidays, including a company-wide summer recharge week in July
• 12 weeks of paid parental leave for employees after 90 days of employment
• Monthly cell phone stipend

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level