Project Engineer (Medical Device)

Looking for a Direct Hire and Client Facing Mechanical Engineer with Medical Device experience and to join our Client's team as the Technical Expert in the Boston area!

We offer a comprehensive compensation package including but not limited to:

• A competitive salary
• Excellent Full benefits (Medical, Dental, Vision, and Life Insurance)
• 401K with match
• Performance based bonuses!!
• Great culture with a supportive and friendly team
• Generous PTO/Sick time
• and More!

Job Details:

We are looking for a passionate and dedicated Permanent Mechanical Engineer to join our team in the Engineering industry. The ideal candidate will have a strong background in mechanical engineering, specifically with experience in the medical device sector. They will be well-versed in Quality System Regulations, Engineering Design, and Medical Device Design. A keen understanding of FDA21, FDA 21 CFR Part 820, ISO13485, and ISO14971 is crucial.

Responsibilities:

• Technical lead for company's Boston Market Clientele of innovative medical device components, with a focus on mechanical engineering aspects including metal parts and electrical component design.
• Well-versed in medical device manufacturing processes, regulations, and being in compliance with FDA and international regulations.
• Collaborate with cross-functional teams to ensure design specifications and standards are met.
• Review and execute design verification activities, including developing protocols and reports.
• Manage and maintain the medical device quality system in compliance with FDA 21 CFR Part 820 and ISO13485.
• Develop and implement manufacturing processes for medical device components.
• Provide exceptional customer service and support to clients, including addressing technical inquiries and concerns.
• Collaborate with suppliers and manufacturers to ensure the quality and compliance of medical device components.
• Communicate effectively with China Factory for customers manufacturing specifications.

Qualifications:

• Bachelor's degree in Mechanical Engineering or a related field.
• Minimum of 3 years of experience in mechanical engineering, preferably in the medical device industry.
• Proficient knowledge of Quality System Regulations, Engineering Design, and Medical Device Design.
• Familiarity with FDA21, FDA 21 CFR Part 820, ISO13485, and ISO14971.
• Experience in designing and developing metal parts and electrical components.
• Proficiency in Mandarin Chinese is a plus.
• Experience in die cutting and fabricating metal components.
• Knowledge of medical device manufacturing and Medical Device Regulations.
• Strong understanding of Manufacturing Processes.
• Experience in verification, creating Verification Reports, and developing Specifications.
• Excellent customer service skills.
• Strong communication and interpersonal skills.
• Ability to work independently and collaboratively in a team environment.
• Detail-oriented with strong problem-solving skills.