Sr. Manufacturing Engineer
US, US, CA - San Diego
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 25%
Location: CA - San Diego
As a Manufacturing Engineer, you’ll take an active part in early stage design and development of parameters, tooling, methods and equipment with the objective of proving process feasibility and creating test parts. Our operations focus on polymer processing using traditional subtractive in conjunction with novel manufacturing methods.
Responsible for assisting in the development, implementation and execution of a Design for Manufacture (DFM) / Design for Assembly (DFA) / Design for Inspection (DFI) program. Responsibilities will also include participation in design transfer to production as it relates to development of manufacturing processes, test/inspection methods, fixturing, gauging and applying inspection and process control techniques. Performs duties in compliance with applicable regulations and standards including FDA Quality System Regulation 21 CFR 820, ISO 13485, and the European Medical Device Directive.
ESSENTIAL JOB FUNCTIONS
- Review designs/prints in both the development and production phases to assure effective use of DFM/DFA/DFI. Reviews will require interaction with interdepartmental personnel such as Development/Design Engineering, Quality Engineering, QC/metrology, Programmers and machinists to create designs and drawings that can be manufactured efficiently with a high confidence of product meeting specifications..
- Advanced knowledge of metal manufacturing processes, especially CNC milling and turning of Titanium, Stainless Steels and PEEK. Other process knowledge including welding, anodization, blasting, laser marking, passivation and assembly is highly desirable.
- Have the ability to read and interpret complex mechanical drawings including advanced
Geometric Dimensioning and Tolerancing (GD&T) applications.
- Support transfer of design to production for product launch and manufacturing transfers to reduce overall product costs and mitigation of business risks.
- Determine appropriate manufacturing methods and strategies to reduce costs and meet critical to quality requirements.
- Identify validation strategies (e.g. IOPQ, GR&R) for processes and/or equipment. Create validation protocols and reports. Manage execution of strategy.
- Support implementation of manufacturing changes that require qualification and/or validation of new equipment or processes.
- Interface with suppliers on technical issues causing inefficiencies, waste or potential supply chain interruptions.
- Understand and use the Change Control Process.
- Lead CAPA process for non-conforming material reports, out of tolerance reports and product complaints that result from manufacturing issues.
- Other functions include:
- Review technical publications, articles, and abstracts to develop applicable skills and to stay abreast of quality, regulatory, compliance, and technical developments in the industry.
- Attend such conferences, seminars, professional meetings, and other public forums as are relevant to the interests of NuVasive.
- Support other work of the Manufacturing, Supply Chain, Development, QE and QA Departments, as required
- Continue to enhance engineering skills and knowledge of spine market through training and education.
- Bachelor’s degree or equivalent work experience
- 5 years experience
- Strong ability to read and interpret complex mechanical drawings including advanced Geometric Dimensioning and Tolerancing (GD&T) applications
- Proficiency in Pro/E / Creo is highly desirable
- Effective communication skills with strong confidence to present before groups of customers, vendors, peers, and leadership
- Proficiency with Microsoft Office with a strong ability to write procedures and reports.
· Experience leading projects on cross-functional teams.
NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The “EEO is the Law” poster options are available here.
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes.The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.