Report

Lead Design Engineer

Salary

₹12 - 20 LPA

Min Experience

3 years

Location

Navi Mumbai, Maharashtra, India

JobType

full-time

About the job

Info This job is sourced from a job board

About the role

Responsibilities

Collaborating with stakeholders to define project deliverables and ensure timely execution.
Designing and development of CADs, prototypes, and transition parts and assemblies from concept to production.
Identifying and mitigating risks, including process and program risks, with robust risk management strategies (e. g., pFEMA).
Supporting validation activities, including developing and reviewing plans and protocols for IQ, OQ, PQ, and other critical processes.
Contributing to cross-functional team objectives and actively engaging in team meetings to align on project goals.
Integrating inspection and test requirements into production plans to uphold quality standards.
Maintaining accountability for assigned projects, ensuring compliance with ISO13485 and other regulatory frameworks.

Requirements

Bachelor's or Master's degree in Mechanical Engineering or a related field.
Minimum 3 years of hands-on experience with CAD modeling (SolidWorks, Fusion360 or similar software).
Thorough knowledge and effective application of Design for Manufacturability, Design for Inspectability, Validation Protocol and Report creation, SPC, Process Control Plans, MSA, Sampling methodologies, and Data Analysis.
Knowledge of GDT and experience in interpreting mechanical drawings.

Nice To Have

Medical device product development and/or manufacturing experience and a strong understanding of FDA, ICH, and IEC standards.
Experience across the entire product lifecycle.
Demonstrate strong problem-solving skills and the ability to ask critical questions without being the subject matter expert.

This job was posted by Mahek Shah from RYMO.

RYMO

cad modeling

solidworks

fusion360

design for manufacturability

design for inspectability

validation protocol

report creation

spc

process control plans

msa

sampling methodologies

data analysis

gdt