Senior, Product Engineer
Senior, Product Engineer
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$ 102400 - 153600
1 Vacancy
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
Provide development support of released production heart valve repair and replacement products that meet application business customer and regulatory requirements. Based on input from business partners prepare schedules and proposals for modifications to designs that meet all Quality and customer requirements. Function effectively as a technical contributor for projects in multi-functional team environment. Collaborate with Manufacturing and Quality colleagues to ensure designs are capable of being manufactured consistently and cost effectively. Document design in accordance with applicable Product Development Protocol Quality and Regulatory requirements. Prepare regulatory submission-ready documentation for the FDA and other regulatory bodies. Support multiple projects within the surgical valve Sustaining/Released Product Engineering group. Provide work direction and training to other engineers and technicians.Careers That Change Lives
At Medtronic we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems make progress and deliver meaningful innovations.
A Day in the Life
Provide development support of released production heart valve replacement and repair products that meet application business customer and regulatory requirements. Based on input from business partners prepare schedules and proposals for modifications to designs that meet all Quality and customer requirements. Function effectively as a technical contributor for projects in multi-functional team environment. Collaborate with Manufacturing and Quality colleagues to ensure designs are capable of being manufactured consistently and cost effectively. Document design in accordance with applicable Product Development Protocol Quality and Regulatory requirements. Prepare regulatory submission-ready documentation for the FDA and other regulatory bodies. Support multiple projects within the surgical valve Sustaining/Released Product Engineering group. Provide work direction and training to other engineers and technicians.
Responsibilities may include the following and other duties may be assigned:
Contribute to the design development and support of existing and modified production heart valve products in a regulated environment.
Support sustaining engineering programs for new and existing products to ensure sustainable and stable operations of production. Identify areas that require additional investigation.
Support manufacturing and quality groups for improvements to existing products in the areas of quality enhancement product cost and product performance.
Analyze and recommend solutions to product issues as a result of product complaints Manufacturing and/or Quality issues.
Review and approve document change orders for design materials and process documentation.
Responsible for production support engineering with respect to testing methods procedures and problems; device specification and yield problems; minor redesign of devices and masks; analysis of customer returns; supplier related engineering changes and optimizing device production relative to cost constraints.
Participate in the specification and direct completion of specific verification/validation testing and analyses required that satisfy both regulatory and internal Medtronic requirements.
Document design modifications in accordance with internal Medtronic industry and regulatory requirements.
Project management. Set project objectives and milestones with initially complex or undetermined outcomes. Provide project planning and management for these multi-functional or cross-business projects.
Work with external suppliers/vendors to establish engineering requirements specifications and agreements.
Organize prepare and present technical information material and current project status in a clear effective and skillful manner to Management and other cross functional colleagues. Prepare tradeoff studies and implement alternative approaches to mitigate schedule delays. Communicates progress and decisions to associates and functional manager.
Must Have:
Bachelors degree in engineering (Mechanic Bio Medical Chemical Biology) and minimum of 4 years of relevant experience or
Advanced degree in Engineering (Mechanic Bio Medical Chemical Biology) with a minimum of 2 years relevant experience.
Requires advanced knowledge of job area combining breadth and depth typically obtained through advanced education combined with experience.
Practical knowledge of project management.
Proven ability to produce effective solutions to product issues with complex technical requirements.
Proven ability to effectively interface with customers and internal clients.
Demonstrated ability to successfully delegate and produce results under aggressive project schedules.
Ability to work effectively in fast-paced rapidly changing engineering environment.
Strong oral and written technical communication skills
Broad knowledge of Manufacturing processes for medical devices design control and Quality Systems.
Detailed working knowledge of risk management analysis including Failure Mode and Effects Analysis (FMEA) analytical and statistical techniques.
Good Manufacturing Practices (GMP)/Quality System Regulations (QSR).
Knowledge of FDA MDD and CMDR
Experience with GMP ISO 13485:2016 and QSR 21 CFR part 820
Nice to Have:
Experience with heart valve product development design control and manufacturing
Green belt Design for Reliability and Manufacturability (DRM) certification
Experience with Design Verification Design Validation and design control (e.g. Product Development Protocol Design History Files and Device Master Record)
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 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.
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.
Employment Type
Full-Time
