|Sr Mechanical Design Engineer|
Engineers and Scientists create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide.
Provide Released Product Engineering support as design point of contact for Therapy Delivery Systems (TDS) leads, catheters & accessories. Collaborate with Reliability, Regulatory, Operations & Sourcing colleagues to evaluate and implement post market design, process, & supplier related change requests. Perform ECR/ECO processing, Where Used Searches/Data Mining, Design Control Evidence (DCE) testing/rationale & other tasks such as: Industry literature searches & reviews to support regulatory renewal submissions, Clinical Evaluation Reports (CER’s) & deficiency responses by providing test & rationale data to regulators. Actively participate in Industry Standard and Regulation reviews for TDS product applicability and compliance.
A Day in the Life:
• Assists Regulatory Specialists by providing design & clinical use data and rationale to support worldwide regulatory submissions and certification renewals. (primary role)
• Supports EU MDR project; assists EU MDR team interpret, remediate, implement new EU MDR regulations (primary role) for project duration
• Identifies and oversees testing required to obtain necessary data to support regulatory renewals, submissions & deficiency responses (primary role)
• Initiates ECR/ECO’s to modify & maintain design documentation (BOM’s, Specs, drawings)
• Reviews and approves changes to manufacturing processes & risk assessments (pFMEA’s)
• Performs critical feature identifications (CFI’s) and design risk assessments (DFMEA’s)
• Supports CAPA’s (Corrective & Preventive Actions) & RPI’s (Released Product Investigations)
• Provides RPE input to new product development teams
• Supports IQ/OQ/PQ, DOE’s, SPC, Gauge R&R, Sampling methodologies, Data Analysis, Hypothesis Testing, Modeling/Predictive Analyses, Capability Studies (CpK), Component Qualifications
• Collaborates with Reliability and Manufacturing personnel to determine & execute appropriate tests/assessments to evaluate supplier, process, material, design, or component changes prior to implementation
• Assists manufacturing sites with lean layout initiatives, interfacility transfers and outsourcing
• Supports cost reduction and continuous improvement projects
• Provides problem solving/trouble shooting support to manufacturing sites and key suppliers to increase yields, maintain process capability & control, and improve efficiency & cost
• Collaborates with Reliability, Manufacturing , Materials, R&D & Safety Engineering to investigate product performance issues/returned product analysis to identify root cause(s) and implement corrective action(s)
• Supports internal and external regulatory compliance audits
• Facilitates cross functional team problem solving & continuous improvement projects
• Serves as liaison between manufacturing sites (MVC, MSO, MIML) & Mounds View support personnel
• Actively participates in NPD to RPE transfers; ensures completion of all transfer deliverables
• Proficient knowledge of Therapy Delivery Systems (TDS) combination products and processes (leads, catheters & accessories)
• Working level understanding of TDS product implant procedures, clinical use conditions, new indications, competitive product landscape & state of the art industry status.
• Proficient knowledge of medical device industry standards, regulations compliance requirements.
• Basic knowledge of silicone & polyurethane molding & bonding, processes & failure modes
• Able to influence course of action for own job area & modify own methods to achieve results in line with overall business needs & objectives.
• Demonstrates good judgment pertaining to issue escalation & consultation with other SME’s
• Able to work independently and exercise appropriate latitude when addressing abstract, yet to be defined technical issues and problems
• Results focused. Able to deliver consistent, high quality work to meet product performance, compliance, schedule, & budget requirements
• Able to provide solutions to a variety of technical problems of challenging scope & complexity.
• Possesses working knowledge of statistical and data analysis tools. SPC, DOE, Gauge R&R, CpK
• Demonstrates clear, factual, & effective, oral and written communication with variety of cross functional colleagues, technical peers, and senior-level management
• Proficient in liaison, collaborator & informal leadership roles. Able to facilitate cross functional group problem solving, decision making, & small projects; including CAPA’s.
• Able to effectively prioritize & work on multiple assignments in parallel & keep stakeholders updated
• Able to work independently, follow established procedures & give/receive technical peer reviews of work deliverables for accuracy of technical content & conclusions.
Bachelor’s Degree in Mechanical Engineering
7+ years of Medical Device Industry Experience
Nice to Have:
• MS in Mechanical or Biomedical Engineering
• Excellent time management skills with ability to manage multiple priorities and deliver on time
• Solid leadership and interpersonal skills including ability to effectively formulate & convey technical and cost/benefit/risk information with peers & senior leaders
• Strong verbal and written communication skills including ability to articulate complex ideas in easy to understand terms
• Working knowledge of Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive, & ISO (13485:2003)
• Knowledge of 6 Sigma, (DFSS) principles
• Able to work well under pressure and maintain positive, engaged, & enthusiastic attitude
• Basic understanding of combination products (familiarity with pharma requirements)
ADDITIONAL PHYSICAL JOB REQUIRMENTS:
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.
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.
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.