The Company
Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple disease states. Based in Silicon Valley and backed by well-known institutional investors, our incredibly talented team of 150+ engineers, innovators and industry leaders brings years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics & Hansen.
The Senior Manufacturing Engineer is responsible for sustaining and identifying and implementing continuous process improvements with an emphasis on process validation. The position will be responsible for on-demand production line support, measure manufacturing driven metrics (cycle times, capacity, bottlenecks etc.), design, duplicate and/or deploy manufacturing fixtures and tooling, develop and train on manufacturing processes and perform equipment qualification and process validation activities.
- Be a leader in process validation (IQ/OQ/PQ/PPQ) for the team, developing the protocols and test processes
- Provide daily support to troubleshoot and resolve manufacturing production issues including material, method, while following GMP and the company Quality Management System.
- Create and revise manufacturing-related risk documents including pFMEA’s and Manufacturing Line specifications
- Identify root cause(s) of operational failures and support Corrective and Preventive Action plans by providing solutions using problem-solving skills including Fishbone, 5 Whys, Pareto Charts etc..
- Generate production metrics including yields, scrap rates, capacity/bottlenecks and cycle times and routinely present to management.
- Define and implement continuous process improvements to existing manufacturing operations including process verification, MFG documentation updates and process validation.
- Perform routine equipment preventative maintenance and/or repair and serve as manufacturing liaison for external calibration activities.
- Design, document, assemble, qualify and release custom and off the shelf manufacturing and testing tooling, fixtures and equipment. Create and release associated maintenance and calibration procedures.
- Author and execute manufacturing documentation, including protocols, reports, manufacturing process instructions, work instructions and equipment/fixture specifications.
- Other manufacturing engineering duties or support as assigned or requested.
- This role requires the use of varying levels of personal protective equipment (including, gowns, masks/face shields, gloves, and safety glasses).
- Degree in Manufacturing/Industrial, Mechanical, or Electrical Engineering
- Minimum 5 years experience in the medical device industry in a manufacturing engineering capacity working with complex hardware/software devices
- Experience in working with CM, especially an OUS CM
- Working knowledge of ISO 13485 and 21 CFR 820.
- Understanding of statistical methods
- SolidWorks or equivalent experience
- Proficient with standard business software (MS Office, Excel, Outlook etc.)
- Excellent written and oral communication skills are required
Consistent with applicable laws, an employee's pay within this range is based on a number of factors which include but are not limited to relevant education, skills, job-related knowledge, qualifications, work experience, credentials, and/or geographic location. Noah Medical reserves the right to modify this range as needed. Please note that the aforementioned range is only one component of the position's total compensation package. In addition, this position may be eligible for bonuses, stock and employee benefits including but not limited to PTO, paid holidays, health insurance, dental & vision insurance, life & disability insurance and a 401k plan. Additional details on the compensation package and employee benefits offerings will be provided to candidates during the interview process.
Noah Medical is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.
To all recruitment agencies: Noah Medical does not accept unsolicited 3rd party agency resumes. Please do not forward resumes to any Noah Medical employees. Noah Medical is not responsible for any fees related to unsolicited resumes and we will not pay fees to any third-party agency or company that does not have a signed agreement with Noah Medical.