About Proven Process

Proven Process is a rapidly growing contract R&D and manufacturing company servicing the health care market. The company offers an exciting and challenging work environment for technical professionals. Benefits include company contributed health plan, company paid dental and LTD Insurance, 401K , paid vacation, and Health Care and Dependent Care Reimbursement Account. Watch this page for open positions as they become available. For more information, please contact Human Resources at 508-261-0812 or email us at hr@provenprocess.com

(no recruitment agencies please)

DESIGN ASSURANCE QUALITY ENGINEER

Overview: The Design Assurance Quality Engineer will work on new product development and improvement teams by qualifying new suppliers, communicating quality/compliance requirements, developing procedures, creating planning documents, approving specifications and providing technical transfer/validation support.

Responsibilities:

• Develop Risk Management Plans for new medical devices
• Conduct design and process Failure Mode and Effects Analysis and hazard analysis, with development team subject matter experts
• Create Verification and Validation Plans and test plans, as directed by project manager
• Design and develop sampling plans and provide statistical guidance, where needed, during the development process
• Participate in and contribute to design reviews throughout the development process
• Plan, develop and execute IQ/OQ/PQs for equipment and processes utilized during design verification, validation and manufacturing
• Create and direct completion of EtO and steam sterilization validation protocols and reports
• Participate in the technical review and approval of design and development documentation
• Trace design requirements to resultant outputs
• Perform internal quality and design control audits
• Assist corporate management in the operation and maintenance of the ISO 13485 and FDA 21 cfr 820 compliant quality system

Qualifications:

• B.S. Degree in Engineering or Life Sciences, advanced degree preferred
• Minimum of 5 years experience in electro-mechanical medical

devices or in-vitro diagnostics design and development

• A.S.Q. CertifiedQuality Engineer or Six-Sigma Black Belt
• A working understanding of FDA Quality System Regulations, ISO 13485, EU directives, applicable standards and guidance documents
• Requires the ability to communicate effectively technical aspects with engineering, operations, management, customers and suppliers, both verbally and in writing
• Requires a motivated individual that is able to work with minimal supervision

ELECTRICAL ENGINEER

Overview: The Electrical Engineer will work with other personnel to design and develop new electro-mechanical medical devices, as well as assist with product testing and validation. Along with company management and engineering staff, the Electrical Engineer will be responsible for various aspects of product development including electronics design, materials procurement, feasibility hardware fabrication, and development and execution of characterization testing. Product validation activities will include test protocol development, participation in product testing, and test report preparation.

Responsibilities:

• Design and develop electronics for various medical devices including medication infusion pumps, patient and in-vitro diagnostic systems, medical robotic systems and other medical products
• Generate design documentation using OrCAD EDA tools for drawings
• Design prototype printed circuit boards using OrCAD layout tools
• Design and execute characterization testing as necessary to verify the design and performance of the device
• Interface with certified test labs to coordinate electrical safety and EMC testing
• Interface with vendors for critical component selection and documentation

Qualifications:

• 7 to 10 years experience developing electronic systems
• Solid experience with embedded microprocessors, embedded single board computers, real-time systems, motor control, and analog and digital signal processing
• Experience using EDA tools (OrCAD experience preferable)
• Experience with printed circuit board layout (OrCAD experience preferable)
• Experience in the medical device industry is required
• A working understanding of FDA QRS or ISO-13485 principles
• A working understanding of UL or IEC 60601 electrical safety and EMC standards and principles
• Requires a motivated individual that is able to work with minimal supervision in a team environment

Education:

• B.S. Degree in Electrical Engineering, Biomedical Engineering, or equivalent
• M.S. degree preferred