MSD
MSD

MSD एक वैश्विक बायोफार्मास्युटिकल कंपनी है, जो कैंसर, संक्रामक रोगों, हृदय एवं चयापचय संबंधी स्थितियों और रोकथाम-केंद्रित देखभाल जैसी प्रमुख स्वास्थ्य चुनौतियों के लिए दवाइयों और टीकों को आगे बढ़ा रही है। संयुक्त राज्य अमेरिका, कनाडा और प्यूर्टो रिको में Merck & Co., Inc. के नाम से जानी जाने वाली MSD वैज्ञानिक अनुसंधान को विकास और वाणिज्यिक विशेषज्ञता के साथ जोड़कर लोगों और पशुओं तक स्वास्थ्य सेवाओं से जुड़े समाधान पहुँचाती है।

इसका कार्य मानव स्वास्थ्य, पशु स्वास्थ्य तथा अनुसंधान एवं विकास के क्षेत्रों में फैला हुआ है, जिससे वैज्ञानिक, क्लिनिकल, वाणिज्यिक, परिचालन और कॉर्पोरेट टीमों में पेशेवरों के लिए अवसर बनते हैं। दुनिया भर के विभिन्न क्षेत्रों में अपनी गतिविधियों के साथ, MSD का करियर-केंद्रित कार्य अनुसंधान, सहयोग, समावेशन और वैश्विक स्वास्थ्य में जिम्मेदार प्रगति पर इसके ध्यान को दर्शाता है।

Senior Medical Device Technical Operations Engineer

Lead engineering work for medical devices and combination products, from design transfer through commercialization. Guide technical operations while meeting quality and regulatory objectives.

विवरण

  • Strengthen engineering capabilities for medical devices and combination products
  • Oversee internal and external manufacturing across development, scale-up, commercialization, and design transfer
  • Provide technical expertise on device components, combination products, and related processes
  • Contribute to global commercialization and technology transfer
  • Improve product robustness for sustained launches while meeting business, quality, and regulatory objectives
  • Use design controls, transfer methods, control strategies, device risk management, and design verification testing
  • Support global manufacturing of components and combination products at internal and external sites
  • Spot early signs of issues, investigate root causes, and develop solutions
  • Establish design engineering practices for medical devices and combination products throughout development and lifecycle management
  • Improve product design and manufacturing with engineering best practices and tools
  • Respond to regulatory agency questions and support pre-approval and other regulatory inspections
  • Plan and carry out strategic technology transfers and problem-solving efforts
  • Lead teams in late-stage development and work with internal and external partners
  • Develop strategic relationships with manufacturing sites and partner groups
  • Ensure work complies with safety, quality, regulatory, divisional, and local-site requirements

आवश्यकताएँ

  • Bachelor’s degree in mechanical engineering, biomedical engineering, or a related technical discipline is required
  • A master’s degree or PhD is preferred
  • At least five years of engineering experience in pharmaceuticals, biologics, medical devices, or combination products
  • At least two years of experience supporting commercial manufacturing
  • Expertise in design controls, risk analysis, control strategies, design verification testing, and process validation
  • Strong knowledge of quality management systems and regulatory compliance
  • Technical experience with injection molding, automation, complex assembly, and packaging operations for medical device or combination product components
  • Direct experience with autoinjectors, ophthalmic products, or inhalation products is strongly preferred
  • Proficiency with ISO 13485, ISO 14971:2019, and other relevant quality management systems
  • Must reside in the United States or Puerto Rico
  • Must be willing to travel 10%
  • Visa sponsorship is not available
  • A valid driver’s license is not required

लाभ

  • Annual bonus and long-term incentive, where applicable
  • Medical, dental, vision, and other insurance coverage for employees and their families
  • Retirement benefits, including a 401(k)
  • Paid holidays
  • Vacation
  • Compassionate and sick leave
  • Hybrid work arrangement
  • Relocation is not required

संबंधित नौकरियाँ

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