Senior Mechanical Engineer

SolidPro - HelixA; Hyderabad; Vor Ort; INR 1.200.000 - 1.800.000; Vollzeit

Zusammenfassung

SolidPro - HelixA is seeking an experienced Mechanical Engineering professional to lead R&D mechanical design for medical devices in Hyderabad. The role emphasizes CAD/FEA, DFMEA, and regulatory compliance across ISO 14971 and related standards, with strong vendor collaboration and PMO alignment.

Applicants should have a track record in design for manufacturability, cross-functional teamwork, and robust documentation. Experience in agile environments and risk management is essential.

Qualifikationen

• Strong mechanical engineering and product design expertise with R&D focus.
• Experience with regulatory standards and DFMEA processes.
• Collaboration with PMOs and global teams on mechanical projects.

Aufgaben

• Collaborate with cross-functional teams to drive mechanical design from concept to validation.
• Contribute to design for manufacturability and cost optimization.
• Support DFMEA, risk analysis, and design documentation updates.
• Assist in supplier/vendor coordination and performance tracking.
• Maintain compliance records and project documentation.

Kenntnisse

CAD/FEA tools

Vendor collaboration

Regulatory compliance

Project management

Agile/Scrum

Documentation

Materials testing

DFM/DFMA

DFMEA

Stakeholder management

Data analysis

Communication

Ausbildung

Biomedical/Mechanical Engineering degree

Masters in Biomedical/Mechanical Eng or Business

Tools

SolidWorks

Creo

AutoCAD

Jobbeschreibung

• Strong proficiency in 3D CAD software (e.g., SolidWorks, Creo, or AutoCAD) and experience with finite element analysis (FEA) tools.


• Experience working with vendor partners on R&D projects, assisting in performance tracking, SLA monitoring, and supporting demand planning to ensure alignment with project requirements.


• Familiarity with medical device product lifecycle management, with experience in applying FDA Design Controls and international standards (e.g., 820-CFR, ISO14971, IEC60601), ensuring compliance with project-specific regulations.


• Experience in supporting project and program management efforts, with a focus on managing day-to-day vendor partner interactions, driving continuous improvement in engineering processes, and contributing to team growth.


• Comfortable working in Agile SCRUM and stage-gate environments, ensuring collaboration with cross-functional teams to meet project objectives.


• Ability to develop and contribute to design documentation, including CAD models, specifications, and compliance records for manufacturability and quality assurance.


• Knowledge of materials compatibility, durability testing, and mechanical design principles, contributing to design solutions to mitigate risks.


• Understanding of manufacturing processes for mechanical components, including injection molding, machining, and rapid prototyping, and experience with managing design for manufacturability.


• Experience with requirements management systems (e.g., DOORS, JAMA), contributing to risk analysis and DFMEA processes in mechanical R&D projects.


• Effective stakeholder management skills, collaborating with PMO teams to ensure technical alignment and timely project delivery.


• Experience working with project data, contributing to technical assessments and identifying opportunities for process improvements and operational efficiency.


• Strong communication skills, with the ability to present technical updates and information clearly to cross-functional teams and stakeholders.

Education

• A degree or higher qualification in Biomedical / Mechanical Engineering from a recognized university.


• Masters in biomedical / Mechanical engineering or business will be an added advantage.

Experience

• 6-10 years of experience in Mechanical Engineering R&D in the medical devices domain, with a strong technical knowledge.


• Proven experience in collaborating with PMOs and global teams on mechanical projects.


• Strong technical background in mechanical design, circuit board development, and compliance with regulatory standards.


• Experience with design for manufacturability (DFM) and design for assembly (DFA) principles.

Required Skills

• Strong technical expertise in mechanical engineering, materials science, and product design, with hands-on experience in R&D and/or sustaining engineering, especially in product development