About the Role

We are looking for an experienced Mechanical Design Engineer to design mechanical systems and enclosures across two distinct but demanding domains: regulated medical products and industrial heavy-weight machinery. This is not a purely conceptual design role the ideal candidate has taken products through certification, manufacturing, and field deployment, and understands the compliance, tolerance, and material trade-offs that come with each.

The role sits close to our active client programs, including medical device development (mechanical, electronics, and application-level integration) and industrial-grade equipment design, so the candidate must be comfortable moving between precision, low-volume medical hardware and rugged, high-load industrial machinery.

Key Responsibilities

Design & Development

- Design mechanical assemblies, enclosures, and structural components for medical devices and industrial/heavy machinery, from concept through production-ready documentation.
- Own DFM (Design for Manufacturing) and DFA (Design for Assembly) reviews for every design before it is released to tooling or fabrication.
- Perform tolerance stack-up analysis, structural/load calculations, and material selection appropriate to each product class (precision enclosures vs. heavy structural frames).
- Work closely with electronics and firmware teams to integrate PCBs, wiring harnesses, sensors, and thermal management into mechanical housings.

Certification-Driven Design (Primary Focus)

- Design with the target certification standard defined from day one — not retrofitted after prototyping. This includes (as applicable to the product):
- Medical: IEC 60601-1 (basic safety & essential performance), IEC 60601-1-2 (EMC), IEC 60529 (IP ratings), ISO 13485 design controls, biocompatibility-relevant material selection (ISO 10993), creepage/clearance and enclosure spacing requirements.
- Industrial/Heavy Machinery: ISO 12100 (machinery safety/risk assessment), IEC 60204-1 (electrical equipment of machines), relevant Machinery Directive/CE or equivalent regional requirements, guarding and pinch-point/ergonomic safety design, structural safety factors for load-bearing components.





- Maintain traceable design history files, risk assessments (FMEA), and verification/validation documentation required to support certification submissions.
- Liaise directly with certification bodies, test labs, and regulatory consultants during pre-compliance and formal testing, and resolve non-conformances arising from test results.

Manufacturing & Production Experience

- Must have hands-on experience taking a design from prototype into actual production — not just released a drawing package and handed it off. This includes:
- Working with contract manufacturers/fabricators on first-article inspection, tooling reviews, and pilot runs.
- Resolving real manufacturing issues (warping, sink marks, weld distortion, fitment failures, fastener pull-out, finish defects) discovered only after parts are physically produced.
- Cost-down iterations after initial production feedback, without compromising certification compliance.

Plastics & Materials Expertise (Special Focus)

- Deep working knowledge of injection-molded and machined plastic components, including:
- Material selection for mechanical, thermal, chemical, and (where relevant) biocompatibility/flame-retardancy requirements.
- Designing for moldability: wall thickness uniformity, draft angles, rib design, gate/weld-line placement, and avoiding warping/sink marks.
- Understanding shrinkage, tolerance capability, and surface finish limitations specific to the chosen resin and molding process.
- Troubleshooting plastic-specific manufacturing defects during tooling trials and production ramp-up.

- Comparable depth in sheet metal, extrusion, and machined metal parts for the industrial/heavy machinery side of the role is expected but secondary to the plastics focus.

Cross-Functional Collaboration

- Work with electronics, software,



and quality teams to ensure mechanical decisions don't create downstream compliance or manufacturing risk.
- Present design rationale and trade-offs clearly to clients and internal stakeholders.

Required Qualifications & Experience

- Bachelor's degree (or higher) in Mechanical Engineering or a closely related discipline.
- 5+ years of mechanical design experience, with demonstrable end-to-end ownership of at least one product through certification and into production.
- Proven experience designing to at least one recognized certification standard (medical, machinery safety, EMC/electrical, or similar) — able to speak specifically about how design decisions were shaped by the standard, not just aware of it.
- Hands-on manufacturing experience: has worked directly with vendors/manufacturers on tooling, first-article builds, or production troubleshooting.
- Strong practical knowledge of plastic part design and injection molding processes, including common failure modes and how to design around them.
- Proficiency in 3D CAD (SolidWorks, Autodesk Inventor, or equivalent) and GD&T.;
- Experience with FEA/structural analysis tools sufficient to justify design decisions for load-bearing or safety-critical components.

Preferred / Nice to Have

- Prior experience specifically in medical device mechanical design (IEC 60601-1 / ISO 13485 workplace).
- Prior experience in industrial or heavy equipment design (frames, enclosures, guarding, structural assemblies).
- Familiarity with EMC/enclosure shielding design considerations for electronics-heavy products.
- Experience preparing or contributing to technical files/design history files for regulatory submissions.
- Exposure to sheet metal, die casting, or CNC machining in addition to plastics.

What Success Looks Like in This Role

- Designs are released "certification-ready" the first time, minimizing rework after formal testing.
- Manufacturing issues are anticipated and designed around before tooling, not discovered after.
- Plastic component designs go through molding trials with minimal iteration.
- Clients and internal teams trust this engineer's sign-off on structural and compliance-critical decisions.

📌 Product Designer (Hyderabad)
🏢 Octopoda Solutions
📍 Hyderabad