Medical Device Project Quality Engineer

Gem Care has a great opportunity for a Project / Quality Engineer in the Maynardville TN area. Starting salary is $75000 per year.

As a Project Engineer in the medical device industry you will be responsible for managing and executing projects related to the development design and manufacturing of medical devices. You will work closely with crossfunctional teams to ensure projects are completed on time within budget and in compliance with regulatory requirements.

MUST HAVE BACHELORS DEGREE IN AN ENGINEERING OR RELATED FIELD AND UNDERSTANDING OF FDA REGULATIONS.

1. Lead the planning execution and monitoring of projects from concept to commercialization adhering to project timelines and milestones.
2. Collaborate with R&D quality assurance and manufacturing teams to define project requirements objectives and deliverables.
3. Develop project plans schedules and budgets and track progress against established targets.
4. Conduct risk assessments and implement mitigation strategies to minimize project risks.
5. Coordinate prototype development testing and validation activities to ensure product performance and regulatory compliance.
6. Support design transfer activities to manufacturing including process validation and production scaleup.
7. Generate and maintain project documentation including design specifications test protocols and regulatory submissions.
8. Communicate project status issues and recommendations to stakeholders including senior management and crossfunctional teams.
9. Ensure compliance with relevant regulatory standards and guidelines such as FDA regulations.
10. Participate in continuous improvement initiatives to enhance project management processes and methodologies.

Requirements :

1. Bachelors degree in Engineering (e.g. Mechanical Biomedical Electrical) or related field.
2. Minimum of 35 years of experience in project management or engineering roles within the medical device industry.
3. Demonstrated track record of successfully managing complex projects from initiation to completion.
4. Strong understanding of medical device development processes including design controls risk management and regulatory requirements.
5. Proficiency in project management tools and methodologies such as Microsoft Project or Agile.
6. Excellent communication and interpersonal skills with the ability to collaborate effectively with multidisciplinary teams.
7. Detailoriented with strong analytical and problemsolving abilities.
8. Knowledge of quality management systems (QMS) and regulatory standards specifically FDA 21 CFR 820.

Remote Work :

Yes

Employment Type :

Contract