Must Have Technical/Functional Skills
- Strong knowledge of theoretical and practical electrical engineering fundamentals, circuit design principles, and experimental engineering techniques.
- Knowledge of Quality Management Systems (QMS) and related tools and methodologies.
- Knowledge of FDA regulations, 21 CFR 211 & 820, ISO 13485, ISO 14971, ISO 17025, and other relevant medical device compliance regulations.
- Understanding of Medical Device Regulatory Standards including MDD/MDR.
- Working knowledge of statistics and Minitab for data analysis.
- Proficiency in electrical CAD/ECAD tools (e.g., Altium Designer, OrCAD, AutoCAD Electrical) to perform design updates and revisions.
- Hands-on experience creating process flow diagrams, developing project plans using Microsoft Project (Gantt charts), and managing complex project schedules.
- Six Sigma certification preferred.
- Knowledge of electronic component selection, PCB design and manufacturing, supplier management, product labeling, packaging considerations, 510(k) submission support, project risk management, electrical verification & validation (V&V).
- Ability to prepare and deliver technical presentations to senior management.
- Excellent interpersonal, communication, organizational, and project management skills.
- Understanding of marketing and market research strategies related to electrical/electromechanical products.
- Strong proficiency with Microsoft Office, Microsoft Project, web tools, and spreadsheet and presentation software.
Salary Range: $95,000- $105,000 a year
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
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