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Sr Quality Engineer NPD

BoulderMedtronic



Senior Quality Engineer - New Product Development

Careers that Change Lives

The NPD Senior Quality Engineer engages in new product development teams to meet quality, time-to-market, and technology objectives through the development and qualification of manufacturing line process. Help streamline and speed our time to market and build quality in every step. You will be a member of the new product development team that supports the design and development of innovative, new products within the Surgical Innovations business.

Impact patient outcomes. Come for a job, stay for a career.

A Day in the Life

The NPD Senior Quality Engineer assists new product development teams in providing guidance on process validation that consistently meet or exceed process quality requirements in a fast paced new product development environment. This person will also be responsible for transferring the line process responsibilities to sustaining resources upon Commercialization Exit. Success requires detailed knowledge of manufacturing methodologies, design control systems, process validation and verification practices, and quality management systems.

Responsibilities Include:

  • Improves process quality performance for assigned product lines
  • Oversees process validation and verification according to FDA requirements
  • Identifies and manages process improvement initiatives through the evaluation and use of the following:
  • Process flow mapping
  • Process FMEA (Failure Mode and Effects Analysis)
  • Control planning
  • DOE (Design of Experiments)
  • MSA (Measurement Systems Analysis)
  • Process capability analysis
  • Statistical analysis
  • Quality inspection procedures, including sampling plans for finished devices
  • Ensures that all tasks are conducted in accordance with Quality System procedures and identifies/implements best practices
  • Organize, perform, and report manufacturing line and documentation audits for new products to ensure process quality
  • Guide engineers and technical support staff on engineering test and build requirements
  • Is a liaison between New product Development teams, Manufacturing, and Sustaining teams
  • Develops positive relationships with New Product Development teams, Operations, and Sustaining to drive quality by design minimizing inspections, defects, and assembly issues
  • Develops and implements innovative solutions to shorten TTM (Time To Market) and improve process quality in conjunction with NPD objectives
  • Assures Corrective Action and Preventive Action plans are developed and executed at assigned process in compliance with the CAPA process
  • Stays informed about advancement in area of expertise and is knowledgeable about new rules, regulations, and standards
  • Is hands-on with the ability to provide insight and direction toward resolving quality and technical issues
  • Execute tactical implementation of strategic plans
  • Oversees the Device Master Record in the Change Order System
  • Assists in designing and improving quality systems, processes and metrics
  • Assist with training cross-functional team members in quality disciplines
  • Applies six-sigma, LEAN, and project management principles to advance NPD objectives
  • Participates in developing QA/RA department strategic plans
  • Contributes to engineering schedules and plans
  • Collaborates and works effectively across functional areas (R&D, Engineering, Mfg., etc.)
  • Prepares monthly progress reports, internal/external formal presentations, and written reports
  • Demonstrates knowledge and understanding of Good Manufacturing Practices and all applicable standards
  • Assures compliance with company Standard Operating Procedures and policies
  • Participates in team decision making, and demonstrates team problem solving and communication skills
  • Maintains a clean, safe, and orderly work area
  • Stops the manufacture and/or distribution of medical devices should it be determined that the safety, quality, identity of the product or process has been compromised
  • Follows all safety procedures and SOP's
  • Other quality related functions as required


Qualifications & Experience
  • BS in Mechanical Engineering, or related field
  • 5+ years of engineering experience
  • 2+ years experience in quality/reliability engineering practice in a regulated environment (FDA 21 CFR, ISO 13485, ISO 9000, FAA, Automotive, etc.)

Must Have: Minimum Qualifications
  • Knowledge of New Product Development Processes
  • Strong knowledge of manufacturing, process validation, and process verification
  • Leadership of or participation in cross-functional and cross-culture teams
  • Ability to work with engineering on requirements, process improvements, measurement system analysis, and capability studies
  • Knowledge of engineering practices, test protocols, and documentation
  • Knowledge of organizational structure and inter-related functions in developing medical devices
  • Familiar with ISO 9001, ISO 13485, and 820 requirements
  • Knowledge of analytical tools and methods, including statistics (Minitab preferred), DOE, and the use of computer/software packages related to design, development, and manufacturing
  • Ability to resolve complex problems requiring detailed analysis, calculation, or experimentation
  • Broad commodity expertise and knowledge of industry practices in area of expertise
  • Strong written and oral communication skills
  • Strong interpersonal and team building skills
  • Skills in personal computer spreadsheet, word processor, and engineering tools
  • Ability to operate light machine tools and metrology instruments
  • Ability to interpret displayed results on metrology instruments
  • Self-starter with strong work ethic and initiative in accomplishing objectives
  • Strong organization and time management skills; ability to manage multiple priorities
  • Attention to detail, thoroughness

Nice to Have

  • Background in six-sigma, LEAN, DFX, and related quality management tools
  • Proven project management skills
  • Ability to lead, energize and influence change efforts at all levels of a complex organization
  • Demonstrated ability to get results through others not under direct supervision
  • Able to work under deadlines and handle multiple detail-oriented tasks simultaneously
  • Able to work independently and across different geographies.
  • Superior interpersonal, verbal and written communication skills; able to communicate effectively and interact with personnel at all levels of technical ability and expertise
  • Proficient in use of Minitab statistical software
  • Excellent problem-solving skills


About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EEO

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

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