Department: Engineering & R&D Services, Location: Switzerland
Work together with HCL Sales directors & Global Engagement manager to manage the customer engagements (Medical Device (Orthopaedics) / pharmaceutical) companies in Solothurn and Basel region, Switzerland. Responsible to Manage various customer Projects and larger team in Switzerland and work closely with teams in India. Support of the regional engineering clusters for Strategy & Organization capabilities and Business continuity and resiliency. Manage Onsite & Offshore coordination across all the projects. Develop long-lasting & trusted partnership with Customer.
Position duties and responsibilities
You will be engaged at one of the well-known Medical Device (Orthopaedics) / pharmaceutical companies in the region of Solothurn and Basel.
- Manage large onsite team in Switzerland & Offshore team in India to manage projects specific to product design and development to Customer.
- Bring the efficiency into the system on various projects handled.
- Project Optimization: With the understanding of various projects, make the recommendation if any to improve project which will improve the timeline / cost.
- Resources spread: Optimize resource model based on spread of understanding the various program. Resource ramp up and ramp down can be streamlined.
- Services offering: How HCL's various service offering can be benefit to the program, make a recommendation and develop the road map for the execution.
- Enabling new Technologies to Customer product portfolio not limited to Single use devices (Plastics), 3D printing etc.., shall be in the Trauma & CMF business.
- Support DHF Remediation, Technical File remediation, Risk Management, DFMEA, PFMEA, Medical regulatory standards -USFDA, EUMDR, MDD, ISO 13485, Protocols, Verification and Validation Testing.
- Manages/coaches his subordinates (on-the-job activities, personal development, appraisal talks, goals, etc.) and recruits new employees if required.
- Drive Quarterly Business Reviews (QBR) and client engagement programs - Develop metrics and drive to improve the same.
- Maintain group budget and track group expenses. Forecast resource requirements - plan for on-boarding/off-boarding. Plan for knowledge management, attrition etc.
- 10%-20% Business Travel if required within Europe & to India.
- Bachelor's degree Mechanical or Polymer Engineering or Process Engineering.
- Experienced professional, who has mastered the job through professional training and extensive experience (min. 12+ years).
- Lean/Six Sigma certificate and experience (process optimization/change management).
- 3-5 years business experience in project management
- Minimum 10+ years of experience in Medical devices especially in Orthopaedic domain is preferable.
- Minimum 5 years of experience in portfolio, Customer engagements, projects & people management expertise on developing and implementing processes for new and existing products.
- Having experience on handled a global team not less than 30 members in Matrix Organization.
- Strong Knowledge in entire Medical product development cycle & Medical device Quality systems.
- Knowledge in CAD software like Creo and in Windchill/Agile PLMs is added advantage.
- Knowledge in Statistical Data Analysis using Minitab and Knowledge in GD&T and Tolerance Stack-up Analysis (2D/3D tools)
- Good hands on experience in DHF Documents, Good Documentation Practice, Medical Devices, ISO 13485 process, ISO 14971 Risk Management, FMEAs, Protocols, Report and Data etc
- Proficient in MS office & Qlik sense
- Knowledge in Plastic materials and manufacturing is additional.
- International working Exposure as an added advantage. Especially having European and Indian cultural awareness is additional.
- Excellent verbal and written communication skills in English required.
- Knowledge in Basic German (A2 / B1 Level) and Indian language (Tamil -Fluent) is additional.
Interpersonal skills / characteristics (if applicable):
- Strong influencing skills - Excellent communication skills (written and oral)
- Problem solving skills - To assist in maintaining project progress and on design issues
- Decision Making - Required to make decisions on technical and management issues
- Extent of Confidentiality - Discretion is essential in view of contact with outside parties, product development strategies & regulatory.
- Strong Leadership. Resilient, Tenacious and Persistent.
- Business acumen & Proven Change Management Skills (Change Integration Process)