Technical Lead, NPI Manufacturing Engineer
Description
Who We Are
Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring 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, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.
About You
- Provide leadership and guidance to the Manufacturing Engineering team (ME) during NPI New Product Introduction through sustaining.
- Manages ME processes, improvements, and execution of time based deliverables
- Implement lean manufacturing principles, drive continuous improvement initiatives, and utilize data analytics to streamline ME operations, increase productivity, and reduce cost in processes.
- Creates and improves processes and procedures for ME and related areas.
- Excellent theoretical, analytical, and practical skills; appropriately applied to resolving manufacturing issues.
- Develops and supports effective product field returns strategy and procedures
- Escalates and resolves design, manufacturability, quality, and supply chain issues
- Responsible for setting up DMR/DHR/LHR management for a complex system
- Creates workflow process diagrams, detailed manufacturing and shipping work instructions, procedures, checklists, travelers, product and equipment maintenance plans
- Develops floor and line layout proposals for build capacity, quality, time optimization and effective inventory management
- Participates in BOM management, technical specification reviews, new part requisitions
- Leads process failure mode and analysis (PFMEA) activities
- Develops and validates critical tests used in production workflow to minimize risk
- Responsible for the activities of validation and qualification of manufacturing equipment and processes utilizing standard qualification approaches (IQ/OQ/PQ)
- Manages development and delivery of completed validation plans, studies, and reports
- Provides feedback for product and process DFM improvements to R&D to ensure optimal manufacturability and serviceability
- Provides technical support in analyzing and/or performing investigation for discrepant production components, assemblies, and field returns
- Assists with assembly, testing, and troubleshooting of new products
- Provides leadership, training, and technical support to production technicians
- Implements fixtures to aid in production, maintenance, and service
- Support Good Manufacturing Practices and quality management system in accordance with FDA regulatory and ISO 13485 requirements.
- Other related duties.
Qualifications
- Minimum a four-year degree (Bachelor’s) in industrial or mechanical engineering or an equivalent combination of education and experience in medical devices with QSR/FDA ISO 13485:2016 or in a highly regulated manufacturing environment
- Need a minimum of 5 years of experience in manufacturing engineering of complex electromechanical devices and medical device
- Must be able to read and understand assembly drawings, BOMs, workflow diagrams, MPIs, and read basic schematics
- Good written and verbal communication skills with all levels of employees, suppliers, and internal customers
- Demonstrates ability to grow in career
#LI-Onsite
Pay Transparency
The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.
Benefits & Perks (For Full Time Employees):
- Competitive Salary
- Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
- Equity & Bonus Program
- Life Insurance (company paid & supplemental) and Disability insurance
- Mental health support through medical insurance programs
- Legal and Pet Insurance
- 12+ paid holidays, Flexible Time Off + Sick Time
- Paid parental leave
- In-office snacks and beverages
- In-office lunch stipend
- Learning & Development Opportunities: On-demand online training and book reimbursement
- Team building and company organized social and celebration events
Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.
Noah Medical is 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.
Please visit our Careers Page to view our latest openings.
NO AGENCIES PLEASE - Please do not outreach to any managers or submit any resumes without a signed agreement from Talent Acquisition. Resumes shared with anyone at Noah Medical without a signed agreement will be considered your gift to us and no fee will be paid.
Skills
As published by greenhouse · 15 questions · 2 written answers
Basics
First Name, Last Name, Preferred First Name, Email, Phone, Resume/CV
Short answers (3)
- LinkedIn Profile optional
- List Name of Employee Referral (If Applicable) optional
- If you answered yes to the above question, and you are currently located in the U.S, please indicate your current U.S. immigration status/visa and type of sponsorship required (if known) optional
Pick from a list (10)
- Do you have at least 5 years of manufacturing engineering experience working with complex electromechanical devices?
- Do you have manufacturing engineering experience in the medical device industry?
- Do you have experience supporting products from New Product Introduction (NPI) through sustaining manufacturing?
- Do you have experience with manufacturing equipment and process validations (IQ/OQ/PQ)?
- Do you have experience working in an FDA-regulated and/or ISO 13485 manufacturing environment?
- How did you hear about this opportunity?
- Are you bound by any non-compete agreements or any other restrictive agreements with your current or former employer that may prohibit or restrict your employment for a position with Noah Medical?
- Are you willing to relocate now or in the future for this position, if you do not currently reside in the location in which this job is based?
- Do you currently, or will you in the future, require any immigration-related support or sponsorship from Noah Medical in order to begin or continue employment with Noah Medical?
- Have you ever worked for Noah Medical in a fulltime, part-time or contract capacity? optional
Written answers (2)
- Please provide your primary mailing address optional
- Do you have any relatives that currently work at Noah Medical? If so please specify their name and relationship to you.