Job Description

• Coordinate engineering projects from initiation through implementation and closure.
• Coordinate cross-functional teams including Engineering, Quality, Regulatory, Operations, Purchasing, Manufacturing and Supply Chain.
• Develop and maintain project timelines, budgets, milestones and resource plans.
• Monitor project schedules and ensure timely completion of tasks across teams.
• Ensure compliance with applicable medical device regulations, company quality systems and internal procedures.
• Support product development through sustaining engineering documentation, identification or cost-reduction opportunities, process improvements, and assistance with transferring projects to manufacturing.
• Facilitate project meetings and drive accountability for deliveries and action items.
• Identify project tasks and assist with developing mitigation plans to minimize impact to timelines and business objectives.
• Assist with engineering change management activities, including documentation and implementation tracking.
• Collaborate with Quality and Regulatory teams to support validation activities, audits and compliance initiatives.
• Maintain accurate project documentation and records in accordance with company and regulatory requirements.

Qualifications

Required Qualifications:

• Bachelor's or associate degree in Engineering, Engineering Technology, Project Management, Business or a related technical field.
• Minimum of 1+ years of project management experience within manufacturing environment.
• Strong understanding of project management principles, scheduling and risk management.
• Experience coordinating cross-functional teams and managing multiple priorities.
• Strong organizational, communication, and problem-solving skills
• Proficient in Microsoft Office Suite and project management tools.

Preferred Qualifications:

• PMP certification or formal project management training.
• Experience working in medical device, healthcare, pharmaceutical or other FDA-regulated industries.
• Experience supporting engineering change requests (ECRs), validation activities or product lifecycle management.
• Experience within a medical device manufacturing environment.

Additional Information

Comprehensive Benefit Package

• 401(k) with Company Match
• Competitive Health, Dental and Vision insurance plans
• Paid Vacation, Holidays and Personal Days
• Paid Life Insurance, Employee Assistance Program and Short-Term Disability

All qualified applicants will receive consideration for employment without regard to race, color, gender identity or expression, age, religion, intellectual disability, mental disability, physical disability, including but not limited to blindness, unless it is shown that such disability prevents performance of the work involved, medical condition, handicap, national origin, ancestry, sexual orientation, marital status, domestic partnership status, parental status, military status, veteran or military discharge status, source of income or housing status or any other status protected by applicable law. GF Health Products, Inc. is a drug free workplace.