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Project Engineer
hace 2 semanas
We are seeking a
Project Engineer
to lead the planning, design, and execution of construction and facility improvement projects within the medical device industry.
This role combines
technical leadership and project management
, ensuring compliance with quality, safety, and regulatory standards such as
GMP, FDA, and ISO 13485
.
Key Responsibilities
- Lead the planning, design, and execution of construction and renovation projects, including cleanrooms, utilities, production areas, and offices.
- Manage project schedules, budgets, and resources, ensuring timely delivery of key milestones.
- Ensure full compliance with
Good Manufacturing Practices (GMP)
,
FDA
,
ISO 13485
, and company
EHS
standards. - Review and validate technical specifications, engineering drawings, and construction packages.
- Collaborate with contractors, architects, and consultants to align designs with operational and regulatory needs.
- Support
commissioning, qualification, and validation
activities for facility systems and utilities. - Lead
Design for Manufacturability (DFM)
and product/process transfer to commercial manufacturing. - Prepare and present technical reports, project updates, and risk assessments to senior leadership.
- Provide input on re-engineering opportunities to improve process performance and product quality.
- Mentor engineers and provide technical guidance to cross-functional teams.
- Oversee installation and validation of new or existing production lines, ensuring regulatory compliance.
Requirements
Qualifications
- Bachelor's degree in Engineering or related field.
- 5+ years of experience
as a Project or Program Engineer in the
Medical Devices industry
. - Fluent in
English and Spanish
(minimum B2 level). - Experience with
risk management
,
ISO 13485
, and
21 CFR Part 820
and their impact on project schedules and documentation. - Proven experience leading validation project plans for medical device products and processes.
- Strong problem-solving, communication, and conflict management skills.
- Experience in product and process transfer projects is a plus.
- PMP certification
is a plus. - MBA
is a plus.