Description
Summary
The Senior Manufacturing Engineer will contribute to all phases of product/process development, transfer to manufacturing, commercial launch, and sustaining support. Support transfer and scale-up of manufacturing to Contract Manufacturing partner(s). Provide technical support as necessary in solving product non-conformances, as well as realizing technical and business opportunities.
Are you curious, creative, and driven? If you are passionate about healthcare innovation, EBR could be the place for you. We seek candidates who are passionate about improving healthcare and motivated to do the hard and exciting work required to bring ground-breaking technology to market.
Essential Duties and Responsibilities
- Participate in equipment, fixture, and tooling development projects to increase quality, capacity, reliability, and yields.
- Participate in technical manufacturing projects that improve yield, reliability, manufacturability, capacity, and cost.
- Perform NPI (New Product Introduction) activities as a representative for Operations group that require commercialization phase of new product(s).
- Perform process validation activities that meet regulatory requirements as well as improve process costs and yields.
- Perform process capability assessments and establish methods to control process output.
- Work cross-functionally with R&D, Regulatory/Clinical Affairs, Sales and Marketing, and Quality Assurance functions to coordinate pilot production of new products.
- Develop and author comprehensive validation protocols and technical reports with minimal supervision.
- Act as a key contributor in process development, troubleshooting, and optimization.
- Conduct thorough Root Cause Analysis (RCA) to identify and resolve process/manufacturing/equipment issues effectively.
Other Duties and Responsibilities
- Provide production sustaining support such as training, documentation updates, and equipment maintenance/repairs.
- Develop and maintain product structure bill of materials.
- Author and implement appropriate design change orders.
- Work with Quality Engineers to investigate product/process failures and collaborate on developing immediate and preventive measures.
- Other duties as assigned.
Required Education, Knowledge, and Skills
- BS in an Engineering discipline such as Mechanical or Biomedical engineering.
- Minimum of 8 years of experience with medical device manufacturing experience.
- Can be an equivalent combination of education and professional experience.
- Knowledge of CAD and drafting tools.
- SolidWorks experience required.
- Knowledge of equipment, tooling, and fixture design.
- Working knowledge of root cause analysis and problem-solving tools for both technical and process issues.
- Proficiency in CNC laser micro welding is a plus.
- Familiarity with catheter design and manufacturing processes is beneficial.
- Knowledge of Lean and Six Sigma tools.
- Working knowledge of cGMP requirements for medical device manufacturing per FDA QSR and ISO13485.
- Ability to sit or stand for up to 8 hours per day.
- Ability to work on a computer for up to 8 hours per day.
- Manual dexterity / fine motor skills, if working with precision equipment.
- Ability to lift up to 20 lbs.
- Ability to distinguish colors if needed to perform the job.
Salary Range
$122,500 - $157,500
Base pay is one part of your total compensation. The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, and alignment with market data.
About EBR Systems
Silicon Valley's EBR Systems is revolutionizing cardiac rhythm disease treatment with its WiSE CRT System technology, eliminating the need for pacing leads. Our dedicated team is committed to providing safe, cost-effective wireless cardiac stimulation therapies for millions of patients.
EBR Systems offers a great place to work as well as generous benefits and growth opportunities:
- Medical, dental, and vision insurance
- 401K
- PTO – starting at 3 weeks per year
- Competitive salary with opportunities for career growth
- Employee stock options
- Life insurance
- Weekly company lunches and occasional happy hour events