B.S. in Electrical Engineering or related field required
10+ years of electrical engineering experience, with 5+ years in a regulated medical device environment
Comprehensive Altium experience for electrical design
Experience with Lean/Six Sigma tools and statistical methodologies preferred
Strong decision-making and problem-solving skills in collaborative settings
Excellent communication skills, both written and verbal
Experience with adhesives and medical device disposables is a plus
Responsibilities
Design and implement manufacturing processes and systems to ensure quality and safety standards
Lead test strategy and development for manufacturing test systems of electrical assemblies
Conduct root cause analysis on test failures and develop corrective actions using six sigma tools
Interface with external suppliers on technical issues and component lifecycle management
Ensure compliance with regulatory standards and quality assurance protocols
Lead cross-functional teams and communicate technical status to senior leadership
Support audits and inspections as a technical representative
Benefits
Stock Options
90% employer-paid medical, dental, and vision insurance
Company-paid Basic Life Insurance
401(k) retirement plan (Traditional and Roth)
Competitive Paid Time Off
Paid Holidays
Flexible Spending Accounts (FSA)
Health Savings Account (HSA)
Employee Assistance Program through PEO
Full Job Description
SUMMARY OF ROLE:
The Principal Electrical Engineer is the senior technical subject matter expert for the electrical design and manufacturing integrity of our commercially released Class III products. This role keeps marketed devices safe, reliable, compliant and cost-effective throughout their lifecycle by resolving production issues, leading test strategy efforts, managing component obsolescence, and driving continuous improvement at both internal and external manufacturing sites. The Principal works across Manufacturing, Quality, Regulatory Affairs, R&D, Supply Chain, and Commercial Operations.
RESPONSIBILITIES:
Design, develop, and implement manufacturing processes, equipment, and systems using knowledge of engineering principles, industry standards, and working design to ensure robust production processes, human work factors, quality, and safety standards.
Lead test strategy and development of manufacturing test systems for released electrical assemblies (PCBAs, sub-assemblies, and finished devices), including test coverage, fixtures, automated test stations, and test software, driving test method validation and transfer to internal and external manufacturing sites to ensure robust defect detection, yield, and compliance
Lead root cause and correlation analysis on test failures and non-conformances to identify and develop corrective actions for solving product and process failures using six sigma tools and scientific and statistical expertise.
Serve as lead subject matter expert to interface with external suppliers and manufacturers on technical issues such as component end of life, yield issues, test development, and supplier change impact assessments.
Deliver work that complies with 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601-1 and applicable collateral and particular standards (including IEC 60601-2-4), and IPC Class 3 workmanship standards.
Lead cross-functional project teams and communicate technical status, risks and recommendations to senior leadership while mentoring and providing technical guidance to engineers across departments.
Support internal and external audits and inspections (FDA, notified bodies, customers) as a technical representative.
Support R&D Engineering to transfer new products & processes into manufacturing
Accommodate periodic international travel to Asia (Thailand, Malaysia)
Perform other duties, as assigned
QUALIFICATIONS:
B.S. in Electrical Engineering, Electronics Engineering, or a related field required
Comprehensive Altium experience creating and modifying electrical design elements
10+ years of electrical engineering experience, with at least 5 years in a regulated medical device environment; substantial experience supporting released products in a manufacturing setting
Experience with Lean/Six Sigma tools and proficiency with statistical methodologies preferred
Excellent interpersonal, writing, and verbal communication skills
Demonstrated ability to balance multiple priorities against aggressive deadlines while maintaining a high degree of quality
Strong decision-making ability and problem-solving skills within a collaborative setting
Experience with adhesives preferred and background with medical device disposables and capital equipment a plus
Strong technical expertise with manufacturing processes, automation, and materials
BENEFITS:
Element Science offers a very competitive salary and benefits package including, but not limited to:
Stock Options
90% employer-paid medical, dental, and vision insurance
Company-paid Basic Life Insurance
401(k) retirement plan (Traditional and Roth)
Competitive Paid Time Off
Paid Holidays
FSA (Flexible Spending Accounts)
HSA (Health Savings Account)
Employee Assistance Program through PEO
The salary for this exempt-level position will be based on experience and qualifications within an established pay range.
