Job Description
We are seeking a seasoned Project Engineer to drive the successful delivery of complex engineering and manufacturing projects within a highly regulated MedTech environment. The role will entail leading end-to-end project execution, ensuring timely completion, within budget constraints, and in compliance with stringent GMP, FDA, and ISO 13485 standards.
The ideal candidate will possess strong technical expertise, excellent communication skills, and the ability to effectively collaborate with cross-functional teams. Experience with automation systems, manufacturing equipment installation, validation protocols, and regulatory compliance is essential.
Key Responsibilities:
1. Lead and support end-to-end project execution, including scoping, design, vendor management, installation, commissioning, and handover.
2. Prepare, review, and execute URS, FDS, FAT, SAT, IQ, OQ, PQ, and validation reports.
3. Manage CapEx projects, including budgeting, scheduling, and resource allocation.
4. Partner with cross-functional teams (Manufacturing, Quality, R&D, Validation, Supply Chain) to deliver project milestones.
5. Drive process improvement initiatives (yield, throughput, efficiency, cost reduction).
6. Ensure regulatory and quality compliance with GMP, FDA, ISO 13485, and EHS standards.
Required Skills & Qualifications
* Bachelors or masters degree in mechanical, Manufacturing, Process, Biomedical, or related Engineering discipline.
* 37 years experience in project engineering within MedTech, Pharma, or Biotech manufacturing environments.
* Proven track record with validation protocols (IQ, OQ, PQ) and equipment qualification.
* Strong knowledge of GMP, ISO 13485, FDA, and EHS regulations.
* Experience in automation systems (PLC/DCS/SCADA) and manufacturing equipment.
* Lean Six Sigma, continuous improvement tools, and problem-solving methodologies.
Career Path
As a Project Engineer, you will have the opportunity to work on diverse projects, collaborating with experienced professionals and contributing to the development of innovative solutions. With experience, you can move into leadership roles, mentoring junior engineers and driving strategic initiatives.