Senior Electrical Component Engineer
2 weeks ago
We are looking for a proficient and seasoned Lead Electrical Component Engineer with a robust background in Electrical Engineering to assess and validate alternative electronic and mechanical components for medical devices. The ideal candidate will operate autonomously or in a leadership capacity, exercising independent judgment in evaluating technical specification documents for alternative parts suggested by Corporate or Third-Party Manufacturers (TPMs). They will be tasked with generating change impact documentation accompanied by technical evaluations to support modifications, collaborating closely with R&D to ensure thorough and precise assessments, and spearheading reviews with cross-functional teams, including Regulatory, Quality Assurance, R&D, Operations, and Global Sourcing.
Key Responsibilities:
- Component Assessment: Analyze technical specification documents and validate alternative electronic and mechanical components based on provided recommendations.
- Project Management: Coordinate and lead the engagement of internal and external resources to fulfill project objectives.
- Business Needs Analysis: Comprehend business requirements and possess a comprehensive understanding of customer and clinical needs related to projects.
- Cross-Functional Collaboration: Lead and/or engage in cross-functional team evaluations and support organizational objectives.
- Technical Expertise: Act as a subject matter expert (SME) or independent technical authority (ITE) on technical issues; interact with senior management, external firms, or agencies; coordinate technical matters across organizations.
- Documentation Management: Ensure timely completion of documentation in accordance with business standards, following up with reviewers for feedback and approvals.
- Regulatory Compliance: Understand and adhere to relevant Environmental Health and Safety (EHS) policies, procedures, rules, and regulations; ensure compliance with applicable corporate and divisional policies, Good Manufacturing Practices (GMP), and perform duties as assigned by management.
Required Qualifications:
- Education: Bachelor's degree in Electrical Engineering (other degrees will not be considered).
- Experience: Minimum of 5 years of relevant work experience (internships, co-ops, school projects will not be considered).
- Regulatory Acumen: Familiarity with cGMP, FDA, and ISO13485. Experience in medical device regulation is essential.
- Engineering Knowledge: Strong understanding of general engineering principles.
- Communication Proficiency: Exceptional written and verbal communication skills, along with considerable patience, are crucial.
- Medical Device Insight: Extensive knowledge of processes involved in the design and manufacturing of medical devices, particularly handheld devices.
Preferred Skills:
- Experience in testing electrical components, primarily off-the-shelf (75%), with 25% customized.
- Hands-on experience with tools such as oscilloscopes for 25% of tasks requiring work beyond data sheets.
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