Job Description
We are seeking a Senior Device Engineer for a direct-hire opportunity in Billerica, MA. This role will support medical device engineering, product development, testing, and technical problem-solving in a regulated environment.
If you have 7+ years of medical device and pharmaceutical experience, knowledge of QSR/GMP regulations, and SolidWorks experience, we’d love to hear from you. Apply today!
Full-time Onsite
Direct Hire
Pay Rate: DoE
Job Summary:
This position provides mechanical and electromechanical engineering for sustaining engineering support for existing medical products as well as new projects.
Area Of Responsibility:
Work Conditions:
Physical Requirements:
Travel Estimate: Up to 10%
Qualification:
Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.
Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.
#IND1
If you have 7+ years of medical device and pharmaceutical experience, knowledge of QSR/GMP regulations, and SolidWorks experience, we’d love to hear from you. Apply today!
Full-time Onsite
Direct Hire
Pay Rate: DoE
Job Summary:
This position provides mechanical and electromechanical engineering for sustaining engineering support for existing medical products as well as new projects.
Area Of Responsibility:
- Provide support for existing products, product investigations, and analysis to determine root cause and appropriate resolution of product issues, and support customer requirements
- Prepare and maintain all necessary product documentation including product specifications, bills of material, hazard/risk analysis, test procedures, and associated validations and procedures and support of suppliers and contract manufacturers
- Perform and complete mechanical tests and or experiments to assure designs meet industry standards, safety margins, reliability goals and international electrical and emission standards as appropriate
- Participate in project teams and assist with project plan definition, estimation, scheduling, tracking, and reporting for related projects
- Ensure that all aspects of the quality system are a high priority in all activities (e.g., design and development activity, validation protocols, risk assessment, etc.)
- Develop specifications, packaging, labeling and all associated design control documents in accordance with project, industry and regulatory requirements
- Contribute to new and supplemental regulatory submissions
- Train and/or provide direction to technicians; may train manufacturing personnel and/or suppliers when required
- Contribute ideas or generate Intellectual Property submissions
- Other duties as assigned
Work Conditions:
- Office
- Lab
- Manufacturing area/clean room area
- Maintenance Shop
- Exposure to noise, hot and cold, outside elements, some radiation
Physical Requirements:
- Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, talk, hear, taste or smell
- Close, distance and peripheral vision; depth perception, ability to focus
- Ability to operate production equipment and hand tools
- Operate hand truck
- Operate computer/office equipment
- Wear proper lab gowning and safety shoes
- Lifting and moving of heavy boxes/equipment up to 70 lbs.
Travel Estimate: Up to 10%
Qualification:
- BS in Mechanical Engineering preferred; Associates in Mechanical Engineering or relevant experience will be considered
- 7 years of experience in the medical device and pharmaceutical industry required
- Ability to interpret and resolve technical and design issues required
- Familiar with QSR / GMP regulations
- Experience with Microsoft Office Tools and Solid Works required
Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.
Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.
#IND1
Numbers & Facts
| Location | Billerica, Massachusetts |
| Industry | Staffing/Employment Agencies |
| Company Size | 100 to 499 employees |
| Website | http://prostaffnj.com/ |
About Company
ProStaff is unlike other staffing or recruiting agencies.
We are a fast growing and successful agency that treats all its clients with a personal touch. Headquartered in South Amboy, ProStaff Solutions is a small group of industry experts—many hailing from larger agencies—who know their business well and enjoy working in a more hands-on and flexible environment, with attention to detail.We all pick up the phones, so it’s not unusual to get our executives on the line when you call. We want to be accessible and accountable to you.
What makes us unique?
Customer service and responsiveness are required of everyone who works at ProStaff. Our mission is to bring the right people to the right job every time. This is not easy, but it can be done.
To accomplish this, we make the effort to learn about your needs and use a careful screening process before we do any introductions. We value your time. If we bring you the wrong candidates or send you to the wrong companies, we’re not doing our job.
ProStaff can handle rush orders with skill, but we always understand our clients before proceeding. That’s why many people are loyal to us. We have worked with blue chip names such as Bed, Bath and Beyond and US Foods, as well as internet-based newcomers such as Blue Apron and Burlington Coat Factory.
Underlying ProStaff’s success are these values:
- Hard work
- Integrity
- Honesty
- Helping the communities we serve
When we uphold our values, ProStaff Solutions Maintains Its good name–which is of utmost importance to us. It’s the heart of our business.
Skills
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