Under general supervision, participate in New Product Development teams to develop
products, design verification tests,
process validations and quality processes
to ensure compliance with company Quality System policies,
procedures, standards (FDA, ISO 13485, CMDCAS, PMDA) and other worldwide regulatory agencies that pertain
to medical devices. Support
production floor activities (IQ/OQ/PQ) and product quality investigations. Work is well defined and is checked for progress and reviewed for accuracy upon completion.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual
must be able to perform
each essential duty satisfactorily.
The listed requirements are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential functions.
responsibilities include assisting in a supporting role on new product development projects.
Assist in the development of effective quality
control and associated risk management plans.
- Write process and product validation protocols and reports,
equipment qualifications, engineering change orders.
- Use statistical tools to analyze
data, make acceptance decisions, and improve
process capability (Six Sigma, SPC, DOE).
- Assist in Failure Mode and Effects
Analysis activities for both Design
and Process FMEA's.
- Help to ensure that development activities follow design control
requirements, product is tested per applicable standards, European Essential Requirements are met per the MOD, and product
is properly transferred to manufacturing.
- Assist in planning necessary
to ensure effective
product acceptance. This includes, but is not limited to, inspection instructions, equipment and gage requirements, and sampling plans.
- Participate in MRB review of nonconforming product;
recommend disposition and corrective action.
- Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
- Assist in complaint
analysis as appropriate.
- Moderate exercise
of judgment is required on details of work and in making selections and adaptations of engineering alternatives.
- Receives general
direction on new aspects of assignments.
- Performs work which involves conventional types of plans, investigations, surveys, structures, or equipment with relatively few complex features
for which there are precedents.
- Specifies inspection and testing
methodologies, mechanisms, and equipment.
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- Recommends revision of specifications to the NPD team.
- Responsible for communicating
business related issues or opportunities to next management level.
- Responsible for ensuring subordinates follow all Company
guidelines related to Health, Safety and Environmental
practices and that all resources
needed to do so are available and in good condition.
- Responsible for ensuring personal
and Company compliance with all Federal,
State, local and Company regulations, policies, and procedures.
- Performs other duties assigned as needed.
REQUIRED EDUCATION/TRAINING and/or
- Bachelor's degree
or equivalent in engineering and/or
- A minimum of 2 years
work experience required.
- Master’s degree preferred.
- American Society
for Quality (ASQ) certification, Six Sigma experience, and/or
knowledge of Process
Excellence tools is desirable.
- Ability to develop and implement Quality standards.
- Knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical
- Knowledge of Quality
Engineering, design control,
and verification and validation (V&V) tools and methodologies.
to apply project management skills to fulfill new product development requirements.
- Auditing and problem
- Exposure to Six Sigma and Process Excellence tools and
methodologies. Lean manufacturing experience desirable.
- Some understanding of business and financial metrics.
- Have a basic understanding of theoretical and practical fundamentals and experimental engineering techniques.
ADDITIONAL POSITION REQUIREMENTS
- Estimate travel
5 - 10%, domestic and international.
- Competent using MS Office (Word,
Excel, PowerPoint, Outlook,
- Ability to multi-task and manage multiple assignments in a timely
- Good verbal
and written communication skills.
- Strong interpersonal skills.
Biosense Webster Inc. (6010)Job Function