Senior Design Lead

Job Summary

EQUIPMENT ENGINEER

Qualifications:

Engineering degree preferred (or equivalent experience) with 4–8 years of experience supporting capital equipment in regulated environments.
Strong understanding of electromechanical systems, automation, and validation.
Hands-on experience with robotics, automation, or custom manufacturing equipment.
Working knowledge of GMP, ISO 13485, FDA QSR, and change control.
Leadership experience supporting audits and quality investigations.

Key Responsibilities:

Own manufacturing/test equipment (robotic assembly, automated test systems, calibration equipment, and custom fixtures)
Lead lifecycle: spec/select -> FAT/SAT -> installation and commissioning ->release to production.
Maintain compliant documentation, including URS/FRS, risk assessments, drawings, PM procedures, change records, and GMP design controls.
Plan and execute IQ/OQ/PQ; support audits, inspections, and traceability validation evidence.
Improve equipment reliability and uptime (MTBF/yield) through RCA/CAPA and preventive/predictive maintenance (CMMS, spare parts, calibration).
Troubleshoot complex electrical, mechanical, pneumatic, robotic, and computer-controlled systems under production pressure.

Skills:

Ability to interpret schematics, wiring diagrams, CAD drawings, and technical specifications.
Expertise in Root Cause Analysis (5 Whys, Fishbone, FMEA) and data-driven decision-making.
Strong technical writing skills for validation documents, reports, and SOPs.
Experience with CMMS, CAD, and engineering documentation systems.
Proven ability to work effectively under production pressure while maintaining compliance and safety.
Strong cross-functional communication skills with Manufacturing, Quality, R&D, and suppliers.
Ownership mindset with the ability to balance short-term operational needs and long-term equipment strategy.
Capability to coach and mentor technicians and junior engineers.

Key Responsibilities

1. To leverage design expertise to ensure that software and products exhibit user-friendliness, intuitiveness, and alignment with user expectations, contributing to the creation of seamless user experiences.

2. To lead a team of designers, provide guidance, and ensuring the delivery of high-quality design solutions in alignment with the overall business goals.

3. To present design concepts and play a crucial role in shaping the overall design vision and strategy.

4. To stay abreast of industry trends, emerging technologies to drive innovation and excellence in design.

Skill Requirements

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Other Requirements

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