Principal Quality Eng
Principal Quality Eng
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Job Description
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
A Day in the LifeMedtronic is currently searching for a Principal Quality Engineer to join the New Product Development team at the Lafayette CO facility. Youll play a crucial role in supporting our Surgical business unit by ensuring that our suppliers deliver high-quality parts materials and service. You will also participate in design transfer and manufacturing quality activities.
Key Responsibilities:
Supplier selection and qualification while ensuring suppliers deliver quality parts materials and services.
Monitor parts from acquisition through the manufacturing cycle promptly identifying and resolving supplier-related problems.
Experience with PCBA suppliers and validation of PCBA test and manufacturing processes strongly preferred.
Develop and prioritize an auditing schedule to ensure suppliers meet GMP and quality standards through regular audits.
Evaluate suppliers internal functions to assess overall performance and provide feedback.
Manage Non-Conformance Material Reports (NCMRs) on materials-related quality issues and trends (Incoming Production Sterilization).
Handle suppliers change requests including communication project management via MAP Agile workflow and regular reporting.
Manage the Approved Supplier List including administrative work in MAP Agile.
Qualify materials through the Production Part Approval Process (PPAP) including process validation test method validation technical writing and project management.
Improve suppliers performance and reduce escapes to manufacturing.
Execute Process validation IQ/OQ/PQ and Master Validation Planning in new product development.
Knowledgeable in Statistical analysis (MSA Capability SPC)
Support DFMEA and PFMEA activities
Identification of critical to quality parameters and process controls in collaboration with designers and cross-functional team
Design Transfer; translating design specifications into production specifications.
Use project management skills to ensure that supplier processes are developing at the appropriate cadence to support engineering builds and Design Verification and Validation.
Provide mentorship and coaching.
The job requires occasional travel to visit suppliers within the United States and internationally.
Must Have: Minimum Requirements
To be considered for this role please ensure the minimum requirements are evident on your resume.
Bachelors degree in engineering or related field
Minimum of 7 years of relevant experience or advanced degree with a minimum of 5 years relevant experience
Nice to Have:
Experience with pcba suppliers and validation of pcba test and manufacturing processes strongly preferred
Medical device manufacturing industry experience preferably ISO 13485.
Lead auditor experience.
Hands-on experience with SAP Trackwise Agile change management.
Ability to manage tasks and projects under tight deadlines with a sense of urgency.
Strong communication and presentation skills with the ability to confidently address external audiences and high-level leadership.
Comfortable navigating through complex networks with diplomatic approaches and reporting to a flattened organization.
Equipped with sophisticated problem-solving methodologies (Lean/Sigma) and great attention to detail to fit for fast-accurate action-driven environments.
Engage in changes and advocate for inclusion/diversity.
Experience with materials and manufacturing processes such as PCBAs MIM nitinol cables crimping laser welding automated functional testing
DRM or DFSS
Knowledge of GD&T
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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities 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. For Office Roles: While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America).
Responsibilities may include the following and other duties may be assigned.
- Develops modifies applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Devises and implements methods and procedures for inspecting testing and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- May specialize in the areas of design incoming material production control product evaluation and reliability inventory control and/or research and development as they apply to product or process quality.
TECHNICAL SPECIALIST CAREER STREAM:An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D systems or initiatives related to new technologies or therapies from design to implementation - while adhering to policies using specialized knowledge and skills.
DIFFERENTIATING FACTORS
Autonomy:Recognized expert managing large projects or processes.
Exercises considerable latitude in determining deliverables of assignments with limited oversight from manager.
Coaches reviews and delegates work to lower level specialists.
Organizational Impact:Contributes to defining the direction for new products processes standards or operational plans based on business strategy with a significant impact on work group results.
May manage large projects or processes that span outside of immediate job area.
Innovation and Complexity:Problems and issues faced are difficult moderately complex and undefined and require detailed information gathering analysis and investigation.
Develops solutions to moderately complex problems and/or makes moderate to significant improvements of processes systems or products independently to enhance performance of job area.
Implements solutions to problems.
Communication and Influence:Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels.
May negotiate with others to reach understanding or agreement and influence decision-making.
Leadership and Talent Management:Typically provides guidance coaching and training to other employees within job area.
Typically manages major / moderately complex projects involving delegation of work and review of work products at times acting as a team leader.
Required Knowledge and Experience:Requires mastery of a specialty area and full knowledge of industry practices typically obtained through advanced education combined with experience.
May have broad knowledge of project management.
Requires a Baccalaureate degree (or for degrees earned outside of the United States a degree which satisfies the requirements of 8 C.F.R. 214.2(h)( 4)(iii)(A) and minimum 7 years of relevant experience or advanced degree with a minimum of 5 years of relevant experience.
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 Responsibilities 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. For Office Roles: While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).
Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.
Learn more about our business mission and our commitment to diversity here.
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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Required Experience:
Staff IC
Employment Type
Full-Time
