Job Summary:
Onsite lead for project teams to ensure projects remain well-organized, on schedule, and aligned with program objectives. This role provides dedicated local leadership to drive planning, coordination, and execution of all activities required to establish compliant, robust, and fully validated manufacturing processes. While not responsible for technical authorship, the Project Manager is accountable for driving schedules, facilitating cross-functional alignment, and ensuring timely completion of all Quality, Regulatory, and Engineering deliverables.
Job Scope:
Project Leadership & Execution
- Lead development and management of integrated project schedules in collaboration with TPMs and functional leads.
- Track project progress, risks, milestones, and deliverables provide routine updates to Operations Management.
- Drive cross-functional alignment across Operations, Process Engineering, Quality, Supply Chain, and global stakeholders.
- Prepare and deliver project dashboards, status reports, risk/mitigation updates, and executive communications.
Design Transfer & New Product Introduction (NPI)
- Coordinate timely delivery of DHF/DMR inputs, specifications, drawings, BOMs, and risk documentation-ensuring completeness without owning technical authorship.
- Facilitate cross-functional completion of DFM, pFMEA, special characteristic identification, and control plan deliverables.
- Plan and coordinate engineering builds, pilot builds, and validation builds, ensuring logistics, documentation, and readiness are in place.
- Guide process development activities including process characterization, capability studies, and optimization for quality and yield.
- Ensure development of process documentation (SOPs, WIs, inspection plans, validated parameter settings).
- Ensure timely resolution of deviations, nonconformances, and validation-related risk mitigations.
- Lead risk management updates related to manufacturing processes and equipment.
- Support internal and external audits associated with the new process or product introduction.
- Ensure materials, equipment, personnel training, and quality controls are fully ready for commercial production.
- Facilitate a smooth transition from project mode to sustained manufacturing.
Requirements:
- Bachelor's degree in engineering, Science, or related technical field.
- 5+ years of experience in the medical device industry, specifically in manufacturing, NPI, or process engineering roles.
- Hands-on experience with equipment installation, commissioning, and FAT/SAT processes.
- Expertise in process validation (IQ, OQ, PQ) within a regulated environment.
- Understanding of ISO 13485, 21 CFR 820, ISO 14971, and medical device quality systems.
- Proven capability in cross-functional leadership and project management tools.
- Regulatory and Quality Focus - Solid foundation in medical device standards and manufacturing compliance.
- Technical Depth - Solid understanding of process development, equipment installation, and validation requirements.
- Execution Discipline - Manages complex project timelines with precision and structure.
- Risk-Based Thinking - Skilled in risk management, mitigation planning, and decision-making under uncertainty.
- Cross-Functional Collaboration - Works effectively across engineering, quality, operations, and global teams.
- Adaptability - Comfortable with ambiguity, changing requirements, and accelerating timelines
Additional Information:
- Salary - Up to S$17K + 1-month bonus
- Contract duration: 12-month contract, extendable
- Commencement Date: Immediate
- Working days and hours: Monday to Friday, 9am to 6pm
- Location: Bugis, frequent traveling to Johor Malaysia
