Senior Engineer, Device Technical Operations (Hybrid)

We need to output HTML fragment with sections: headings

for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections if posting has real specific content. Must not repeat job title as heading. Must not include Job ID etc. Remove boilerplate, navigation, legal, EEO, scam warning, duplicated lines, application instructions. Must preserve all substantive info. Must not invent or summarize away detail. Must not include placeholder text like "commensurate with experience". Must not create Pay/Schedule/Benefits unless posting actually states them. The posting includes salary range: "The salary range for this role is $117,000.00 - $184,200.00". So we can include Pay section. Benefits: "We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days." So Benefits section. Schedule: Not mentioned; there is "Travel Requirements 10% Flexible Work Arrangements Hybrid Shift 1st - Day". That's schedule info: hybrid shift, 1st - day, flexible work arrangements, travel 10%. So we can include Schedule section with that info. Must not include placeholder. Also "Relocation: No relocation", "VISA Sponsorship No", "Valid Driving License No", "Hazardous Material(s) n/a". Those could be considered schedule? Might be other details but not required. We'll include schedule with hybrid, travel, etc. We need sections: About the role (Job Summary), Responsibilities (Essential Duties And Responsibilities), Qualifications, Skills (Required Skills, Preferred Skills), Benefits, Pay, Schedule. Possibly also Requirements? The posting has "Requirements" heading but then it's EEO boilerplate. We should not include that as it's boilerplate. The actual qualifications are under "Qualifications". So we can omit Requirements section. We must not repeat job title. Use

for each section heading. We need to preserve all substantive info: job summary, duties, qualifications, skills, benefits, pay, schedule. We must not include application instructions, links, etc. So remove "You can apply for this role through ...", "application deadline", etc. Also remove "Current Employees apply HERE", etc. Remove EEO, accommodation, etc. Remove "Search Firm Representatives", etc. Remove "Job Posting End Date", etc. Remove "Requisition ID". Remove "Relocation:", "VISA Sponsorship", "Valid Driving License", "Hazardous Material(s)"? Those are specifics; maybe include under Schedule or a separate section? Not required headings. Could include them in Schedule as additional details. But schedule heading is for schedule info; we could include those under Schedule as well. However they are not schedule. Could create a separate section like "Additional Details" but not in allowed headings. The instruction says use headings for those specific categories; we can omit if not fitting. Better to include them under Schedule? Might be okay to include under Schedule as "Work Arrangements". But we need to avoid inventing headings not listed. We could add a

under Schedule that includes those details. Or we could create a separate

after schedule for miscellaneous. The instruction: "Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It doesn't forbid other headings, but says use those for those sections. It says "Prefer a few substantive sections over many thin ones." So we can stick to those headings and put miscellaneous info in appropriate sections (maybe Schedule). Let's put schedule info: "Hybrid shift (1st - day), 10% travel, flexible work arrangements, no relocation, no visa sponsorship, valid driver's license not required, no hazardous materials." That seems okay. Now we need to extract duties list: It's a paragraph with many sentences. We should convert to

• for any list of duties/requirements/benefits. The duties are multiple sentences; we can split into list items each duty. Let's parse: - Utilize extensive experience in design controls, design transfer, control strategies, device risk management, and design verification testing to develop value-added solutions for medical devices and combination products. - Provide support for internal and external component manufacturing and combination product manufacturing, globally. - Identify issues with minimal signals, problem solving, identification of root cause provides solutions. - Build design engineering mindset for medical devices or combination products in both development and lifecycle management, ensuring compliance with relevant regulatory standards. - Use engineering best practices and tools to optimize the design and manufacturing to ensure robust technical and programs decisions through the development and commercialization teams - Support responses regulatory agency questions and pre-approval inspections during product development and life cycle management - Develop and execute strategic plans for technology transfer, problem-solving, leading teams in late stages of development, and working collaboratively with external and internal partners. - Foster a culture of inclusion by integrating inputs and perspectives from various sources to meet customer and stakeholder needs. - Build strategic partnerships with manufacturing sites and partner groups - Ensure that all activities are conducted with the highest regard for safety, quality, and regulatory compliance, aligning with the company's divisional and local site procedures. - Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems. We'll make each a
• . Qualifications: bullet list? It's paragraph with semicolons. We'll split: - Bachelor’s degree in mechanical engineering, biomedical engineering, or a related technical field (e.g., Chemical Engineering, Materials Engineering) required; advanced degree (Master's or PhD) preferred. - Minimum of 5 years of experience in pharmaceutical, biologic, medical device or combination product engineering, with at least 2 years supporting commercial manufacturing - Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process validation, with a strong understanding of quality management systems and regulatory compliance. - Demonstrated technical experience in injection molding, automation, complex assembly and packaging operations for medical device or combination product component manufacturing. - Direct experience in autoinjectors, ophthalmic products, or inhalation products highly preferred. We'll make each a
• . Skills: Required Skills list: "Construction Processes, Design Controls, Deviation Management, Driving Continuous Improvement, Engineering Leadership, Engineering Support, Ethical Compliance, GMP Documentation, Materials Science, Mechanical Engineering, Performance Monitoring, Process Development Engineering, Product Engineering, Root Cause Identification, Technology Development". We'll make each a
• under Required Skills heading. Preferred Skills: "Current Employees apply HERE Current Contingent Workers apply HERE US And Puerto Rico Residents Only". That seems like nonsense; actually the preferred skills section is garbled: after "Required Skills" there is list then "# PRD # eligibleforERP Required Skills Construction Processes, ..." then "Preferred Skills Current Employees apply HERE Current Contingent Workers apply HERE US And Puerto Rico Residents Only". That seems like misplaced. The actual preferred skills likely missing; but we have no real preferred skills content. So we should not create a Preferred Skills section if no real content. The instruction: "include a section ONLY when the posting has real, specific content for it". So we will not include Preferred Skills heading. But we have "Required Skills" heading; we can include that as Skills section? The instruction says use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have a Skills heading and list required skills under it. We'll not split required vs preferred; just list required skills. Now Benefits: we have list: medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. We'll make each a

  . Pay: we have salary range and mention annual bonus and long-term incentive. We'll include that as

  maybe with details. Schedule: we have hybrid shift, 10% travel, flexible work arrangements, no relocation, no visa sponsorship, valid driver's license not required, no hazardous materials. We'll make a

  or

  ? Since it's not a list of duties, we can use

  . Now we need to strip out boilerplate: EEO, accommodation, application instructions, etc. Let's craft HTML:

  About the role

  The Senior Engineer - Device Technical Operations position is a key engineering role within the Device Development and Technology Organization. This position is responsible for building strong engineering capabilities related to medical devices and combination products. The individual is also responsible for managing internal and external manufacturing in the development, scale-up, commercialization, and design transfer of medical devices and combination products, with a focus on complex drug-delivery systems such as autoinjectors, ophthalmic products, and inhalation products. The Senior Engineer - Device Technical Operations role is a technical subject matter expert on the device components, combination products, and processes to support global commercialization and technology transfer activities and drive product robustness for sustained launch in alignment with the company's business goals, and quality and regulatory compliance.

  Responsibilities

  • Utilize extensive experience in design controls, design transfer, control strategies, device risk management, and design verification testing to develop value-added solutions for medical devices and combination products.
  • Provide support for internal and external component manufacturing and combination product manufacturing, globally.
  • Identify issues with minimal signals, problem solving, identification of root cause provides solutions.
  • Build design engineering mindset for medical devices or combination products in both development and lifecycle management, ensuring compliance with relevant regulatory standards.
  • Use engineering best practices and tools to optimize the design and manufacturing to ensure robust technical and programs decisions through the development and commercialization teams
  • Support responses regulatory agency questions and pre-approval inspections during product development and life cycle management
  • Develop and execute strategic plans for technology transfer, problem-solving, leading teams in late stages of development, and working collaboratively with external and internal partners.
  • Foster a culture of inclusion by integrating inputs and perspectives from various sources to meet customer and stakeholder needs.
  • Build strategic partnerships with manufacturing sites and partner groups
  • Ensure that all activities are conducted with the highest regard for safety, quality, and regulatory compliance, aligning with the company's divisional and local site procedures.
  • Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems.

  Qualifications

  • Bachelor’s degree in mechanical engineering, biomedical engineering, or a related technical field (e.g., Chemical Engineering, Materials Engineering) required; advanced degree (Master's or PhD) preferred.
  • Minimum of 5 years of experience in pharmaceutical, biologic, medical device or combination product engineering, with at least 2 years supporting commercial manufacturing
  • Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process validation, with a strong understanding of quality management systems and regulatory compliance.
  • Demonstrated technical experience in injection molding, automation, complex assembly and packaging operations for medical device or combination product component manufacturing.
  • Direct experience in autoinjectors, ophthalmic products, or inhalation products highly preferred.

  Skills

  • Construction Processes
  • Design Controls
  • Deviation Management
  • Driving Continuous Improvement
  • Engineering Leadership
  • Engineering Support
  • Ethical Compliance
  • GMP Documentation
  • Materials Science
  • Mechanical Engineering
  • Performance Monitoring