Design Controls Engineer Consultant III
We are looking for a Sr. Design Controls Engineer for a position in Andover, MA
The Sr. Design Controls Engineer position will be part of the company's Andover Quality Transformation group and report to the E2E Project Manager (Risk Management), Systems Engineering Engineer. The position will focus on E2E design controls processes and risk management related engineering activities.
This Sr. Design Controls Engineer will be responsible for the technical leadership and acceptability of the application of the Risk Management Process. The scope includes ownership of the risk management process and procedures, identify need and support training activities for the effective application of the risk management process, lead risk management activities and act as technical liaison to the risk management process, support BUs in requirement management and design specification activities, identify and facilitate the process interfaces, enable design reviews and coordinate risk management file reviews.
location: Andover, Massachusetts
job type: Contract
salary: $80 - 90 per hour
work hours: 8 to 5
This is a key and critical role within the Risk Management Group within the Monitoring Analytics & Therapeutic Care (MA&TC). This is an opportunity to become part of a well-seasoned winning team that owns the risk management process and supports its effective deployment for all MA&TC medical devices / products. The risk management team plays a very important role in ensuring products designed by company are of the highest quality and meet all applicable international standards.
Define and shape the End2End Risk Management processes
- Lead and support the safety and quality vision embedded in the risk management process to BUs and team members.
- Lead and coordinate efforts to establish product safety and reliability goals and to plan, execute and monitor activities aimed at achieving those goals.
- Provide technical depth of knowledge, coaching and training in system engineering tools and methodologies like uFMEA/dFMEA/pFMEA, DoE, Design Verification, Engineering Analyses, CTQ/CTS flow down.
- Support site wide training on risk management and product reliability/quality best practices.
- Provide support for the application of the risk management process to all BUs, identifying the interfaces between the functional areas involved in the creation and sustainability of medical devices that are safe and effective.
- Lead the definition, documentation, implementation and improvement of risk management policies, processes and practices.
- Act as technical liaison to cross functional teams in the implementation of the risk management process.
- Support the BUs in translating safety/reliability/quality requirements into Design Control measures by means of the use of system engineering methodologies.
- Review BUs risk management files to ensure that they comply with the requirements of the risk management process (and applicable standards).
- Support investigation activities for the determination of root causes of product and performance deviations (e.g. CAPAs and HHEs).
- Ensure compliance with the design control process and with the Quality Management System.
- Provide in-depth technical support and foster a culture of effective Risk Management practices.
- BSEE /MSEE with 20 year experience in the design and development of medical devices combining multidisciplinary engineering fields and technologies (i.e. electric/electronic, mechanic, computer, connectivity, system engineering, etc.).
- Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international, namely the IEC/ISO 60601-1 family of standards, including collateral and particular (part 2) application standards.
- Application knowledge of design controls and risk management processes in compliance with ISO 13485 and EN/ISO 14971 standards and global regulations (i.e. FDA, EU, CFDA, etc.).
skills: - Experience with FMEA, APQP is highly desirable
- Demonstrate ability to lead, communicate, interact and influence effectively at technical levels across functions.
- Demonstrate competence in the use of system engineering tools and methodologies.
- Highly passionate and positive infectious attitude who strives for high performance and product safety and quality.
- Ability to effectively implement continual improvement to increase effectiveness of the risk management process.
- Proficient in standard office computer tools: Microsoft Office, Word, Excel, Project and PowerPoint.
Excellent English skills, written and speaking.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.