Position – R-D Engineer II
Company – Medtronic
Location – Hyderabad, Telangana, IN
Careers that Change Lives
Medtronic’s Cardiac Rhythm Management (CRM) business within the Cardiovascular Operating Unit is looking for a motivated engineer to work in a mechanical engineering role for Released Product Engineering (RPE). Medtronic CRM is the industry leader and our products are complex engineering systems. The Mechanical Engineer II position responsibilities will include investigating mechanical related issues with post-market implantable devices such as pacemakers (IPG’s), defibrillators (ICD’s), cardiac monitors (ICM’s), and cardiac resynchronization therapy (CRT) products. This role involves a close working relationship with new product development to improve future products. The candidate should have demonstrated the ability to manage activities on multiple projects.
A Day in the Life
Description Responsibilities may include the following and other duties may be assigned.
- Interact with personnel on technical matters often requiring coordination between organizations
- Identifies and oversees testing required to obtain necessary data to support field actions, regulatory renewals, submissions, and deficiency responses
- Provide a critical evaluation of device design when representing design in the review of Change Impact Forms (CIF’s)
- Initiates change activity (CA) to modify or maintain design documentation (BOM’s, Specs, drawings)
- Supports CAPA’s (Corrective & Preventive Actions) and RPI’s (Released Product Investigations) including possible CAPA ownership
- Provides RPE input to new product development teams
- Assists regulatory specialists by providing design & clinical use data and rationale to support worldwide regulatory submissions and certification renewals.
- Supports IQ/OQ/PQ, DOE’s, SPC, Gauge R&R, Sampling methodologies, Data Analysis, Hypothesis Testing, Modeling/Predictive Analyses, Capability Studies (CpK), and Component Qualifications
- Collaborates with reliability and manufacturing personnel to determine and execute appropriate tests/assessments to evaluate supplier, process, material, design, or component changes prior to implementation
- Collaborates with cross-functional partners to investigate product performance issues/returned product analysis to identify the root cause(s) and implement corrective action(s)
- Assists manufacturing sites with lean layout initiatives, interfacility transfers, and outsourcing
- Supports cost reduction and continuous improvement projects
- Provides problem-solving/troubleshooting support to manufacturing sites and key suppliers to increase yields, maintain process capability, and improve efficiency and cost
- Supports internal and external regulatory compliance audits
- Actively participates in new product development to RPE transfers; ensures completion of all transfer deliverables
Must-Have / Minimum Qualification
- 5- 8 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
- Bachelor Degree in Mechanical Engineering / Advanced Degree
- Knowledge of CRHF devices (ICD’s, IPG’s, CRT-D/P, ICM)
- High proficiency in using internal systems such as MAP Agile, Enovia, CATS, and Documentum
- Basic level understanding of CRHF product implant procedures, clinical use conditions, new indications, competitive product landscape & state of the art industry status
- Knowledge of medical device industry standards, regulations compliance requirements
- Basic knowledge of mechanical processes, materials, processes, PFMEA and DFMEA
- Demonstrates good judgment pertaining to issue escalation and consultation with other SME’s
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Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.