Director, Device Engineering

Reports To: Executive Director, Device Engineering FLSA Status: Exempt Job Type: Full-time About Accord: Accord is a global provider of generic and specialty pharmaceuticals. Our focus on a rapidly expanding portfolio of affordable generic medicines of exceptional quality standards has made us one of the fastest growing US generic and specialty companies. Position Overview The Director, Device Engineering is a strategic, hands‑on technical leader responsible for the end‑to‑end development, industrialization, and lifecycle management of drug–device and biologic–device combination products. This role ensures compliance with FDA (21 CFR Part 4, 21 CFR 820), EMA/MDR, ISO 13485, ISO 14971, IEC standards, and other global regulations. The Director will lead cross‑functional engineering activities that drive design, development, verification, validation, technology transfer, and ongoing commercial support for Accord’s device and combination product portfolio. This includes strong emphasis on design control, human factors engineering, risk management, supplier oversight, and manufacturing readiness from concept through post‑market support. Essential Functions, Duties and Responsibilities The following duties are considered essential to the role. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Lead end to end development, manufacturing, and lifecycle management of combination products (e.g., prefilled syringes, autoinjectors, on body injectors) in full compliance with global regulatory requirements. Serve as the device subject matter expert across all development phases, including design development, verification, validation, risk management, human factors, and process validation. Define system architecture, assess design feasibility, lead material selection, guide prototyping, and ensure high quality technical documentation. Ensure seamless integration of drug product, device components, packaging, and delivery systems through effective collaboration with cross functional teams. Conduct and oversee design for manufacturing (DFM), reliability engineering, tolerance analysis, DOE, and design reviews. Develop and maintain design requirements, Design History Files (DHF), and Technical Files in alignment with Accord’s ISO 13485 Quality Management System. Lead risk identification, analysis, evaluation, and mitigation using ISO 14971 methodologies (e.g., hazard analysis, design FMEA, process FMEA). Provide oversight of human factors engineering, including use related risk analysis, formative evaluations, and summative validation studies. Develop and execute verification and validation test plans, protocols, and reports. Provide technical direction for device test method development and validation, test fixture design, and laboratory execution. Oversee external partners such as CMOs and test laboratories to ensure successful GMP production, assembly, and testing. Author, review, and provide technical inputs to regulatory submissions for drug device combination products. Serve as device SME in regulatory agency interactions, partner audits, and technical due diligence. Partner with CMOs and global suppliers to ensure robust clinical and commercial manufacturing readiness. Lead technical investigations for deviations, complaints, and nonconformances; drive root cause analysis and corrective/preventive actions. Support ongoing process monitoring, scale up, and continuous improvement initiatives. Lead post market engineering activities, complaint investigations, change management initiatives, and product sustainability programs. Evaluate and implement design improvements, cost reductions, and supply chain optimizations while maintaining regulatory compliance. Provide onsite troubleshooting and support at manufacturing or supplier locations as needed. Occasional domestic and international travel required. The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position. An individual in this position must be able to successfully meet the expectations listed above. Education and Experience Bachelor’s degree in Mechanical engineering, Biomedical Engineering, Chemical Engineering, or related scientific field 6‑8 years of relevant industry experience in drug delivery device or medical device development and clinical/commercial manufacturing Demonstrated experience leading device development through commercialization. Experience with developing drug‑device combination products preferred Background in engineering of electro‑mechanical and disposable medical devices is preferred Must have experience with industry standard design and development tools (CAD, math modeling, tolerance analysis, and statistical software) Deep understanding of: FDA and EMA regulations for combination products ISO 13485, ISO 14971, IEC 62366, IEC 60601 series (as relevant) Drug–device integration and design control requirements Strong track record in managing external suppliers, CMOs/OEMs, and global manufacturing partners. Excellent communication, documentation, and leadership skills. Complete knowledge of Quality System Regulation, including Design Controls is required Experience with guiding GMP investigations at contract vendors Knowledge, Skills, and Abilities Strategic thinker with ability to translate business needs into technical strategies. Strong problem‑solving and analytical mindset. Ability to influence and lead across functions. Adaptable, collaborative, and comfortable in fast‑paced environments. Proven ability to deliver high‑quality, compliant development outputs consistently. Must work well in cross‑functional teams and be able to communicate effectively with external partners, peers, and senior management Must have prior experience managing third‑party relationships Must have strong negotiating and interpersonal skills, and the ability to clearly present recommendations Must have excellent decision‑making, leadership, interpersonal, verbal and written communication skills Must have strong computer skills, including all MS Office applications Physical/Mental Demands and Working Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. This position operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. The role requires extended periods of sitting and computer use. Some walking, standing, bending, or carrying of light items (up to 10 lbs) may be required. Accord provides equal employment opportunities (EEO) to all employees and applicants for employment consistent with applicable local, state or federal law. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Only short‑listed candidates will be contacted. Accord Healthcare is an equal opportunities employer. All applications are treated as confidential. To apply for this job, send your details, CV, and relevant documents View email address on click.appcast.io #J-18808-Ljbffr Accord Healthcare Inc