Sr. Manufacturing Quality Engineering – Systems

San Jose, CA, United States

Sr. Manufacturing Quality Engineering – Systems San Jose

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 The Team:

The Manufacturing Quality Engineer reports to the Manufacturing Quality Engineering Lead or equivalent manager. This position provides hands-on guidance and leadership from a Quality and Regulatory perspective to the team throughout the product development cycle, especially with V&V and Design Transfer stages. The focus is to provide engineering support so high-quality products can be produced in a world class manufacturing infrastructure. We are looking for someone that is highly motivated in their career growth, a self-starter, a team builder, and an excellent communicator.

The role will collaborate closely with cross-functional teams to ensure efficient manufacturing operations, optimize production schedules, meet customer demands, improve processes, support NPI, scale production, improve the factory, own safety and facilities, while maintaining high-quality standards.

A Day In The Life Of Our Sr Manufacturing QE – Systems :

Develop and support Product Final Acceptance processes.

Engage in procedure validation and improvement activities.

Provide hands-on leadership and guidance to Design Transfer requirements, Risk Management, Manufacturing processes, incoming and in-process inspection and test methods/specifications, Process Validation (including sterilization), and finished product release activities.

Participate in new product development teams and represent Quality function as needed. Provide relevant input to the product development planning process according to project milestones and QMS implementation /requirements/trace matrix.

Define, implement, and provide training on relevant aspects of Noah Medical’s Quality Management System to meet US FDA and International requirements.

Grow in QE/QMS expertise as defined by the manager.

Participate in QE/QMS activities not specified here and as assigned.

Review equipment documents and ensure all defined requirements are met.

Collaborate well with team members throughout Noah organization.

Support Good Manufacturing Practices and quality management system in accordance with FDA regulatory and ISO 13485 requirements.

About You:

Education: BS degree in a technical field or equivalent.

BS in Engineering or Technology, Mechanical, Industrial, Electrical, Manufacturing, Life Sciences, or equivalent.

Minimum of 6 years of Engineering work experience in the medical device field and a minimum of 4 years’ experience in a QE/Mfg. function or equivalent.

Experience in production environments that meet world class regulatory requirements such as ISO/FDA Quality Management System requirements.

Experience in inspection/test method development and validation for IQC, In-Process, and Final release requirements.

Experience with electro-mechanical assembly.

Experience with SPC and data analysis using six sigma tools.

Experienced with Process Validation including sterilization validation.

Experience in supplier selection, qualifications and improvement.

Experience with Risk Analysis, FMEAs, Hazard Analysis.

Experienced with statistical skills to define/train on test sample size and data analysis techniques.

Experienced in Microsoft Office and other software tools such as Google Suite and ePLM/eQMS systems, or equivalent.

Must have attention to details, be a self-starter, a team builder, and excellent in verbal and written communication.

Prior manufacturing experience in a medical device company, preferably on surgical robotics or equivalent highly complex medical devices.

Strong team player with proven history of success working in a multi-disciplinary, cross functional team.

Strong verbal and written skill with the ability to communicate effectively across functions and levels in the organization.

Excellent people and project management skills

Experience in MRP systems, MS office and related office automation systems.

Experience in Medical Device Design Control processes preferred.

Workplace Type:  Onsite

Benefits & Perks (For Full Time Employees):

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, 15-20 days of PTO + use-what-you-need sick days

Paid parental leave

In-office snacks and beverages

Learning & Development Opportunities: On-demand online training and book reimbursement

Team building and company organized social and celebration events

Pay Transparency

The Pay Range for this position is listed. 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 of the posted role. Noah Medical reserves the right to modify this range as needed based on candidate experience level and/or specialized skills. Please note that the aforementioned range is only one component of the position's total compensation package.

$106,800 — $133,500 USD

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.

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Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Noah Medical’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

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