Senior Engineer, Manufacturing at TalentBurst

Senior Engineer, Manufacturing
Full Time
Fremont, CA, US

JOB SUMMARY

The Sr. Manufacturing Engineer will work as a member of a multi-disciplinary team to develop and manufacture robotic devices for orthopedic surgeries. Project scope may include new and next generation products, improving effectiveness for existing products, line extensions, manufacturing technology transfers, and general product improvements. Seeking an individual who can work independently on complex tasks including assessing product designs for manufacturability, process prototyping, testing, data analysis, and report writing. This position is based in the Fremont, CA office.

DUTIES & RESPONSIBILITIES

• Serve as the primary manufacturing SME between R&D and manufacturing operations.
• Use manufacturing and assembly process knowledge to clearly communicate feasibility of the design with respect to manufacturing implementation.
• Provide technical direction to the vendor when designing the manufacturing process design from pilot concept to full-scale manufacturing, including requesting process changes to support the intended design.
• Compile and evaluate test data to determine appropriate limits and variables for process or material specifications.
• Resolve manufacturing problems and provides procedures and processes for manufacturing facilities.
• Conceive, define, and plan projects involving selection of new manufacturing concepts, equipment automation technology, and risk-based approaches when developing new or improved processes.
• Mentor other engineers and cross-functional stakeholders.
• Work with engineering team(s) to develop final product solution for chosen architecture within time and cost constraints.
• Ensure that the most cost-effective manufacturing processes and procedures are used.
• Provide input on equipment purchases (in accordance with capital plans) to ensure they are technically suitable for the purpose intended and consistent with production plans and needs.
• Develop new manufacturing practices as needed to ensure that manufacturing costs, technique and quality are kept current with external industrial practices.
• Review cost and qualities of development and manufacturing processes and recommend improvements in processes and techniques.
• May perform other duties and responsibilities as assigned.

QUALIFICATIONS

Required:

• B.S in Mechanical Engineering or equivalent field.
• Minimum 5-7 years' experience in Process development, preferably within medical devices.
• Hands-on experience in manufacturing and assembly of complex electro-mechanical devices, including assembly between metal components to injection molded components.
• Strong history in application of Design for Manufacturability (DFM) and Design for Assembly (DFA) to perform tolerance stack-up within components and sub-assemblies.
• Demonstrated application of Gage design and tolerancing.
• Direct experience in a CNC machining environment with demonstrated success in process selection and troubleshooting. Ability to work hands-on and assess vendor processes to improve product throughput and quality.
• Demonstrated experience with fixture development (assessment, design, fabrication, implementation) and equipment procurement, and troubleshooting
• Experience in investigating, diagnosing, and troubleshooting of product complaints down to the component level.
• Experience in assessing fabrication processes based on component design, including but not limited to metal casting, forging, injection molding, and plastic machining.
• Experience developing PFMEA, Control Plan, SOP and PPAP generation associated with product & manufacturing transfers and launches either internally, to supplier/vendor or between suppliers/vendors
• Experience manufacturing electromechanical high tolerance products at scale, including machined, cast forged, PCBA and cables and plastic components.
• Strong knowledge and background in medical device manufacturing and associated regulations like 21CFR 820 or other standards like ISO 13485
• Hands on experience developing and executing IQ/OQ/PQ
• Experience in DOE development and execution, capability analysis, data collection, and reporting
• Experience with Test Method development for in-line and end of line testing
• Desire and ability to work in both an office and workshop environment by combining formal education with hands-on work in the shop
• Strong communication skills with experience with direct customer interface and vendor management.
• Able to actively listen and convey understanding of the comments and questions of others
• Persuasiveness to influence change.
• Strong experience with SolidWorks.
• Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) or equivalent, and email skills required
• Ability to work independently

• Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System

Standards.

Preferred:

• Experience with PLCM software such as Propel, Project Management Software such as Confluence and Smart-sheet.
• Experience with medical device hardware, electrical, and software development.
• Experience with sterile medical instrumentation and disposables, in a regulatory environment.
• Strong knowledge of fundamental Quality and statistical tools.

COMPETENCIES

• Drives results
• Optimizes work processes
• Defends design and process choices.
• Hold stakeholders accountable.
• Decisiveness in the face of constraints.

PHYSICAL DEMANDS & WORK ENVIRONMENT

• Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.
• Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.
• Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.
• Occasionally work around moving mechanical parts.
• Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.
• Must be able to travel as business necessitates (up to 20%).

Disclaimer:

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be possible to enable individuals with disabilities to perform the essential functions.