Development Sr Engineer I Sustaining

You have a key support role with significantly expanded responsibility for development, commercialization, and sustaining engineering relative to electrical systems and subsystems. You contribute to innovative medical device products that further Zimmer Biomet’s mission and support market leadership. Additionally, you will apply appropriate new technologies, contribute technical guidance within cross-functional teams, and support the development of less experienced engineers as needed.

Work Location: Bangalore Work Mode: Hybrid (3 Days in office) Shift Timing - 11:00 AM - 8:00 PM

Maintains working knowledge of relevant medical electrical standards, regulatory requirements, and internal procedures.

Supports sustaining engineering activities, including evaluation and implementation support for design changes.

Supports post-market and quality investigations by providing technical input, testing support, and product evaluation expertise.

Leads assigned workstreams or smaller-scale projects for sustaining activities, or product change initiatives with guidance from leadership as needed.

Coordinates with cross-functional team members on prototype builds, inspection activities, and execution support for design verification, design validation, and process validation activities.

Identifies and documents critical-to-quality product features based on intended use, design requirements, user risks, and the design itself.

Executes and supports verification and validation activities to confirm product designs meet requirements and appropriately address user risk in compliance with Zimmer Biomet procedures and regulatory expectations.

Supports Quality, Sourcing, and Manufacturing teams with design transfer activities for product launch and production readiness.

Develops and executes test methods, engineering evaluations, and supporting validation activities required by Zimmer Biomet procedures and applicable regulatory requirements.

Authors and reviews design control and risk management documentation, and supports cross-functional alignment throughout the product development process.

Creates and communicates project timelines, task plans, and status updates to stakeholders for assigned engineering activities.

Coordinates with project team members and tracks assigned tasks to support delivery to timeline.

Identifies project risks, escalates issues appropriately, and contributes to contingency planning with stakeholders and team members.

Monitors product performance and relevant technical literature to support sound engineering decisions and continuous improvement.

Provides technical guidance to less experienced engineers and cross-functional partners on product design and development activities.

Evaluates and applies new technologies, tools, or methods where appropriate to improve product performance and address user needs.

• Demonstrated good written and verbal communication skills, able to deliver professional communications to a global audience base • Microsoft Office Suite software proficiency required • Demonstrated product design and development execution with a multi-disciplinary project team from user need identification/concept ideation through commercialization desired; medical device particularly orthopaedic implant and instrument product design desired • Demonstrated a general understanding of various electrical/electronic manufacturing processes (including printed circuit board assembly manufacturing,) and material science for application in new product development/sustenance. • Experience in electrical hardware end-of-life changes for PCB assemblies, LCD displays, batteries, and sensors, including obsolescence assessment, component replacement, design impact evaluation, hardware verification, and implementation in a regulated environment. • FDA QSR and EU MDR medical device regulatory requirements, and industry/regulatory body recognized technical product standards knowledge required; global medical device regulatory requirements knowledge preferred • Design and testing of printed circuit board assemblies for embedded and electrical systems using an enterprise level EDA package such as Mentor Graphics or Altium. • Experience with embedded microprocessor design, schematic capture, printed circuit board layout and simulation tools. • Strong understanding of hardware interfaces and I/O (SPI, UART, A/D, D/A. I2C, CAN. LVDS, MIPI, etc) • Ability to execute board bring-ups by using advanced debugging and troubleshooting techniques. • Board level EMC design experience, supporting product level EMC test and EMC issue resolution. • Bluetooth and wireless design experience desired. • Motor control experience especially with BLDC desired. • Li-ion battery pack management desired. • Demonstrated working knowledge of statistics with application to sample size determination, design of experiments and null hypothesis testing preferred. • Minitab experience preferred.

Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Electrical Engineering or Electrical Engineering Technology.

5+ years of full-time engineering experience, preferably in medical device product development or a similarly regulated environment.

Electrical/ Electronic hardware experience

MDR, PCB Design, EMC Design, MS Office suite

Obsolescence assessment, LCD displays, batteries, and sensors (any 3 of 4)

Graduation in Electrical/ Electronic Engineering - Education qualification

Good to have:

Medical device regulations/FDA

Altium

Verification and Validation

Embedded Software

Up to 5%

EOE/M/F/Vet/Disability