Senior / Program Engineer (Healthcare)

Responsibilities:

• Develop and maintain detailed project plans, schedules, and risk assessments to guide project execution and mitigate risks.
• Coordinate cross-functional activities across Engineering, Tooling, Quality, Manufacturing, and Supply Chain teams to achieve project milestones.
• Monitor project progress and deliverables to ensure alignment with timelines and quality standards.
• Identify, document, and escalate project risks, issues, and resource constraints to management for timely resolution.
• Facilitate regular project review meetings and provide clear status updates to management and customers.
• Coordinate tooling development, qualification, and validation activities including IQ, OQ, PQ, MSA, and process capability studies.
• Collaborate with process engineers to establish and optimize robust molding processes.
• Ensure all project activities comply with customer specifications and applicable regulatory requirements.
• Support customer audits, project documentation reviews, and regulatory submissions as needed.
• Manage change control processes by documenting and securing approvals for all changes.
• Review customer RFQs, drawings, specifications, and quality requirements to assess project feasibility.
• Conduct feasibility studies in collaboration with Engineering, Tooling, Quality, Manufacturing, and Supply Chain teams.
• Participate actively in customer meetings, technical discussions, and project reviews to maintain alignment and address concerns.
• Maintain strong customer relationships and serve as the primary point of contact during project execution.
• Take reasonable care of workplace health and safety by following EHS policies and cooperating with management and colleagues in EHS initiatives.
• Perform other duties as assigned to support project and organizational goals.

Requirements:

• Diploma or Degree in Engineering or equivalent.
• 3-5 years of relevant project management experience.
• Strong project management and organizational skills demonstrated by managing multiple projects simultaneously.
• Excellent communication skills with the ability to engage effectively with customers and internal stakeholders.
• Strong analytical and problem-solving skills applied to identify and resolve project challenges.
• Ability to work independently, show initiative, and multitask effectively in a fast-paced environment.