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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing production assembly tasks in a regulated manufacturing environment, ensuring compliance with ISO 13485:2016 and FDA Quality System Regulation. Proficient in training and mentoring teams while maintaining high-quality standards and effective communication.
Highest-signal resume keywords
ISO 13485:2016 ComplianceFDA Quality System RegulationElectro-Mechanical TroubleshootingCleanroom Assembly ExperienceTeam Management and Coaching
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Production AssemblyBlueprint ReadingSolderingElectro-Mechanical WiringPCBA HandlingProcess ImprovementQuality System ComplianceGMP UnderstandingGDP UnderstandingTroubleshooting
Soft Skills
Problem-SolvingOrganizational SkillsEffective CommunicationNegotiation SkillsConflict Resolution
Tools & Technologies
Manual Torque ToolsElectronic Torque ToolsInspection ToolsMicroscopesUltrasonic Cleaning TechnologiesWire CuttersCrimping Tools
Certifications & Qualifications
OSHA Safety CertificationCPIMCMS
Industry Keywords
Regulated ManufacturingProduction LinesQuality SystemCleanroom StandardsElectro-Mechanical Systems
Tech Stack
Tools & technologiesAssembly
About the role
Key responsibilities & impact- Perform and ensure production assembly tasks are completed to meet production schedules while maintaining high quality
- Work alongside the team to assemble products and complete projects within time standards
- Manage multiple production lines and resolve production issues
- Train employees and assign tasks to the operations team
- Support and comply with Company Quality System requirements
- Maintain a safe and clean work environment
- Communicate job expectations; plan, monitor, and appraise job results
- Coach, counsel, and discipline employees
- Initiate, coordinate, and enforce systems, policies, and procedures
- Complete production plans by scheduling and assigning employees, establishing priorities, monitoring progress, revising schedules, and resolving problems
- Follow standard operating procedures and written work instructions
- Complete documentation for business and regulatory requirements
- Perform chassis and final-build product assembly
- Read blueprints, assembly instructions, and hardware callouts
- Recruit, train, and mentor employees
- Perform soldering tasks
- Test finished products for defects
- Wire electronics and complex assemblies and panels
- Take on special projects and other assigned duties
Requirements
What you’ll need- 5+ years in a regulated manufacturing environment
- Experience in an ISO 13485:2016 and FDA Quality System Regulation (21 CFR 820) compliant manufacturing environment preferred
- Understanding of GDP (Good Documentation Practices) and GMP (Good Manufacturing Practices)
- Prior supervisory experience
- Training experience
- Cleanroom assembly experience, preferably ISO Class 7, beneficial
- Experience working to time standards
- High School graduate
- OSHA Safety certification, CPIM, and CMS a plus
- Team management and coaching
- Ability to read and interpret blueprints, work instructions, and procedure manuals
- Ability to follow wire run diagrams for electro-mechanical system wiring
- Strong mechanical and electrical aptitude
- Electro-mechanical troubleshooting experience
- Experience using manual and electronic torque tools, wrenches, wire cutters, crimping tools, soldering tools, inspection tools, microscopes, and ultrasonic cleaning technologies
- PCBA handling, integration, and connectivity
- Understanding of proper ESD practices
- Assembly of pneumatic and fluidic systems
- Strategic planning and process improvement
- Strong organizational, problem-solving, negotiation, and conflict-resolution skills
- Ability to communicate effectively orally and in writing
- Ability to work collaboratively
- Ability to regularly lift/push/carry 30 pounds and sometimes up to 45 pounds
- Full range of motion for wrist, hand, and finger dexterity
- Ability to frequently sit, stand, walk, stoop, kneel, and crouch
- Ability to see up close and from a distance for assembly and evaluation
Benefits
Comp & perks- Medical, Dental, Vision Insurance
- 401(k)
- Paid Time Off
- Long-Term & Short-Term Disability
- Life Insurance
- 10 Paid Holidays
- Additional Voluntary Benefits
