Product Development Specialist - Voice Center
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POST DATE 8/27/2016
END DATE 11/22/2016
Massachusetts General Hospital(MGH)
JOB DESCRIPTIONGENERAL SUMMARY/ OVERVIEW STATEMENT:
Utilizing medical device development experience, participate on cross functional teams to design and develop medical devices. Conduct testing and analyses in collaboration with contract labs and manufacturers to ensure the device(s) conform to project directives and timelines and meet established compliance and quality standards (e.g. ISO 14971 and ISO 13485). Assist in managing work at contract manufacturers. Manage Design Control Program. Prepare plans, documentation and reports.
Must be highly collaborative and work effectively on inter-disciplinary teams. Must be a goal oriented self starter who is able to work with minimal supervision.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
* Participate on a cross functional team with product design and development of a medical device in compliance with FDA QSRs and ISO 13485 requirements.
* Participate with a cross functional team with risk management activities in compliance with ISO 14971.
* Manage the Design Control program and generate risk management plans, design and process FMEAs and risk management reports.
* Conduct preventative maintenance, calibration and maintain records of manufacturing equipment at contract manufacturing site(s).
* Develop specifications, detailed work instructions, and manufacturing and inspection process routers, device master records and get them executed at Contract manufacturing site(s).
* Create and manage project plans.
* Prepare verification and product and process validation protocols and reports.
* Maintain a design history file and perform document control activities.
* Mentor and train others in product development.
* Interface with outside contract manufacturers, consultants and suppliers.
* Keep good documentation records of research and development efforts with traceability for FDA and ISO requirements.
* Manage corrective and preventive action.
* Complies with intellectual property safeguards.
* Complete other projects and assignments as needed.
Requires a minimum of 3 years of industrial experience in the design and development of medical devices with knowledge of risk management, validation and design control. Experience with sterilization of medical devices, clean rooms and clean room validation preferred.
Bachelors Degree required with Masters degree preferred, preferred field of study: engineering, chemistry or life sciences.
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
Skilled in design of medical devices with strong knowledge of design requirements, risk planning, testing and compliance
Complies with good design and manufacturing practices, technical guidelines, intellectual property requirements and regulatory mandates
Able to work in a hands-on technical manner on problems that are diverse in scope in a proper and safe manner
Has a good judgement and sound knowledge of various technical alternatives and their impact
Statistical design of experiments, process flow diagrams, device design controls, process simulation and other engineering software, etc. are preferred
High level of skills in Word, Excel and MS Project required
Understanding of mathematical modeling techniques and an understanding of statistics including design of experiments are important. Knowledge of statistical control, Six Sigma, and other design for excellence method will be a benefit
Solid experience with 21 CFR 820 and ISO 14971 is a must
Excellent communication skills, both written an oral, and effective organizational skills to keep device development on track with plans and timelines
Is knowledgeable and compliant in all hospital, State and Federal regulatory requirements, including hospital policy and procedures (where applicable to the performance of the job), Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and Health Insurance Portability and Accountability Act of 1996 (HIPAA)
Normal office conditions. Travel to contract sites is expected about 20% of the time.
Prudent use of resources and supplies
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.