Discover your career path with us

What We Are Looking For:
Are you passionate about working in a “Core Biomedical Company” and making a real impact on lives? Join Happy Reliable Surgeries Pvt. Ltd. as a Clinical Engineer (Fresher/Experienced) and be part of a dynamic team supporting complex surgeries across India.

We’re looking for candidates who:

• Understand Human Anatomy & CT/MRI
• Are eager to learn and grow
• Can work closely with Neurosurgeons & OT staff
• Are open to Pan-India travel

JOB DESCRIPTION:

Role: Clinical Engineer (Bio-Medical)
Location: Pan India (Preferable North, East & West Regions)
Qualifications: B. TECH/B.E. (BIOMEDICAL / MEDICAL ELECTRONICS OR relevant).
Experience: 0–4 years’ experience.

Skills Required:

1. Knowledge of anatomy, physiology, and basics of electronics.
2. Good communication and interpersonal skills are necessary to work effectively with surgeons, OT staff, and fellow employees.
3. Able to work in an operation theatre environment with the OR staff.
4. He/she should be flexible to travel PAN India and Abroad.

Tasks & Activities:

• Surgery support (Demo & post sales).
• Installation of medical devices at the customer end.
• Troubleshooting medical equipment.
• Training of Medical Devices to Hospital staff and Surgeons.
• Software troubleshooting during on-field assistance.
• Maintaining relationships with renowned Neurosurgeons, KOL, and other stakeholders.
• AMC / CMC and service procedures.
• Demo Inventory management and timely report to head office.

Be a part of something meaningful — where Technology Meets Purpose and every day helps Save Lives.

Position: Production Head
Location: Bangalore
Department: Manufacturing

Role Summary:
We are looking for an experienced and strategic Production Head to lead our manufacturing operations in the medical device domain. The ideal candidate will have deep knowledge of regulated production environments, strong people management skills, and a passion for driving quality, safety, and efficiency. This role is critical to ensuring that our products meet global standards and are delivered on time and within budget.

Key Responsibilities

• Lead and oversee all daily manufacturing activities, ensuring production targets, t imelines, and quality standards are met.
• Develop and implement effective production strategies aligned with company goals.
  Ensure full compliance with regulatory and quality standards, including ISO 13485, FDA 21 CFR Part 820, and EU MDR.
• Manage cleanroom operations and ensure adherence to safety and hygiene protocols.
• Plan and optimize resource allocation including manpower, materials, and machines.
• Implement and promote Lean Manufacturing, 5S, Six Sigma, and other process improvement techniques.
• Coordinate with cross-functional teams such as Quality, R&D, Regulatory Affairs, SCM, and Maintenance.
• Oversee preventive and corrective maintenance of production equipment and ensure minimal downtime.
• Ensure documentation practices meet Good Manufacturing Practices (GMP), including DMR, DHR, CAPA, NCR, etc.
• Train, mentor, and lead the production team to drive productivity and accountability.
• Participate in internal, external, and regulatory audits.

Qualifications:

• Bachelor’s/Master’s degree in Mechanical / Industrial / Biomedical Engineering or related field.
• Certifications in Lean, Six Sigma (Green/Black Belt), or ISO 13485 are an advantage.

Experience:

• 12–20 years of experience in manufacturing, with at least 5 years in the medical device or pharma industry.
• Prior leadership role in managing large-scale, regulated production lines.

Key Competencies:

• In-depth knowledge of regulatory standards (ISO 13485, GMP, FDA, EU MDR).
• Excellent team leadership, communication, and conflict-resolution skills.
• Proven track record in implementing continuous improvement and cost-saving initiatives.
• Hands-on experience with ERP/MES systems.
• Strong analytical and decision-making abilities.

Why Join Us?

• Opportunity to lead in a fast-growing, innovation-driven organization
• Work on cutting-edge medical technologies that impact lives
• A culture that values quality, teamwork, and continuous learning

Be a part of something meaningful — where Technology Meets Purpose and every day helps Save Lives.

Role Summary:
We’re looking for a dedicated QA professional with hands-on experience in medical device quality systems, compliance, and documentation. someone who thrives in a fast-paced, highimpact environment.

Role: QA Specialist
Experience: 3 To 5
Location: Bangalore

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• 3–5 years of experience in QA roles with strong focus on documentation and compliance in the medical device industry.
• In-depth knowledge of ISO 13485, FDA QSR, EU MDR, and risk management (ISO 14971).
• Proven experience with QMS documentation management and inspection/audit readiness.
• Familiarity with risk management tools (e.g., FMEA, Hazard Analysis).
• Strong attention to detail and high standards for documentation accuracy.
• Experience in a startup or fast-paced, resource constrained environment preferred.
• Excellent written and verbal communication skills.

Preferred Qualifications:

• Certified Quality Auditor (CQA), Six Sigma, or similar certifications.
• Experience with software as a medical device (SaMD) is a plus.
• Familiarity with electronic QMS systems (e.g., MasterControl, Greenlight Guru, Qualio, SimplerQMS, ETQ, and Qualityze EQMS).

Skill Required:

• Contribute to building and maintaining our QMS in line with ISO 13485, FDA 21 CFR Part 820, EU MDR and so on.
• Own and manage CAPAs, non-conformances, and change controls.
• Support risk management activities (ISO 14971) and product lifecycle management.
• Work cross-functionally with engineering, regulatory, and manufacturing teams to support design controls and risk management.
• Support and prepare for audits and inspections (internal and external).
• Assist in regulatory inspection readiness and participate as SME where needed.
• Develop, revise, and maintain quality documentation (SOPs, work instructions, protocols).
• Support the development and maintenance of Design History File (DHF) and Device Master Record (DMR).
• Help implement electronic QMS tools suitable for a growing organization.
• Monitor and analyze quality metrics and trends to identify improvement opportunities.
• Participate in supplier evaluations, audits and ensure ongoing quality compliance.
• Review and approve quality documents including SOPs, work instructions, protocols, and reports.
• Maintain document control and training systems per QMS requirements.
• Ensure quality-related training programs are current, effective, and fully documented.
• Support complaint handling and post-market surveillance activities (as applicable).

Be a part of something meaningful — where Technology Meets Purpose and every day helps Save Lives.

Role: Regulatory Affairs Specialist
Experience: 3 To 5
Location: Bangalore

Minimum Education:
Bachelor’s degree in a scientific, engineering, or regulatory-related field (advanced degree preferred).

• 3–5 years of experience in regulatory affairs within the medical device industry.
• Experience with FDA regulations (21 CFR Part 820), EU MDR, ISO 13485, and international regulatory frameworks.
• Proven track record of preparing regulatory submissions (510(k), Technical Files, etc.).
• Start-up or small company experience highly desirable.
• Excellent written and verbal communication skills.
• Strong project management skills and ability to manage multiple priorities in a fast-paced environment.
• Detail-oriented, proactive, and adaptable.
• RAC (Regulatory Affairs Certification) or equivalent professional certification.
• Experience with Software as a Medical Device (SaMD) or digital health products.
• Prior experience leading or contributing to regulatory strategy for first-time product submissions. Familiarity with international regulatory pathways (e.g., TGA, NMPA, PMDA).
• Knowledge of clinical evaluation requirements under EU MDR.
• Familiarity with risk management per ISO 14971 and usability engineering per IEC 62366.
• Ability to thrive in an unstructured environment and contribute to the creation of scalable regulatory processes.

Skills Required:

• Develop and implement regulatory strategies to support product development and commercialization in target markets (e.g., India, US, EU, Canada).
• Prepare, submit, and manage regulatory submissions such as 510(k), CE marking under MDR, and Health Canada license applications.
• Interface with regulatory agencies, managing pre-submissions, responses to requests for information, and ongoing communications.
• Maintain current knowledge of regulatory requirements, guidance documents, and industry best practices and ensure timely compliance.
• Work cross-functionally with R&D, Clinical, Quality, and Marketing to ensure regulatory requirements are integrated throughout the product lifecycle.
• Review and develop product labels and assess promotional materials for compliance with relevant regulations and technical standards.
• Support creation and maintenance of the Technical Documentation/Design Dossier.
• Assist in the development and implementation of internal regulatory processes, SOPs, and best practices.
• Monitor and interpret regulatory changes that may impact products and provide strategic input accordingly.
• Evaluate incidents/complaints related to devices for medical device reporting obligations. Compile and submit reportable events to the appropriate regulatory bodies promptly.
• Support Quality Management System (QMS) activities, including audits, CAPAs, and compliance initiatives as needed.

Be a part of something meaningful — where Technology Meets Purpose and every day helps Save Lives.

We are a product-based Medical Devices company focused on providing State of the art Surgical Navigation Systems. Only a handful of companies across the world develop computer-assisted surgery solutions. We are proudly The First Indian Company in this domain and strive to make India Self-reliant in this highly specialized domain. We operate in the complex areas of Neuro & Ortho surgeries with our teams and systems closely assisting surgeons in the live OT environment. We provide our clients with World class accuracy and we provide our employees with the best benefits. HRS Navigation is currently in the growth stage and is clocking exponential growth year after year.

Qualifications: Bachelor’s or Master’s degree in computer engineering or computer science.
Experience: 3–6-year experience.

Skills Required:

• Strong experience in C++, QT.
• Strong experience in OOPs, Design patterns, Data structures, algorithms, etc.
• Experience with QT, VTK, OpenCV, etc preferred.
• Experience in Windows/Desktop applications is preferred.
• Experience working with Waterfall / Agile development technologies.
• Experience creating and maintaining databases.
• Knowledge of system frameworks including .NET, Git, and GitHub.
• Knowledge of the software development life-cycle.
• Good interpersonal skills.
• The desire to work in a fast-paced environment.

Tasks & Activities:

• Create and implement leading-edge reusable algorithm solutions.
• Implement high-quality code with comprehensive unit testing.
• Troubleshoot and resolve issues raised.
• Directing programming and development documentation.
• Working on new software programs, websites, and applications.
• Assigning tasks to junior developers such as coding, testing, debugging, and analytics.
• Training staff / Onsite clients on software use.
• Incorporate new technologies into the products.
• Create technical and regulatory documents for the project.

Be a part of something meaningful — where Technology Meets Purpose and every day helps Save Lives.