Senior Device Engineer

Lupin; Town of Florida (NY); On-site; USD 120,000 - 160,000; Full time

Job summary

Lupin Pharmaceuticals Inc. is expanding its US R&D footprint to advance generic and branded products, including medical devices and combination products. The role centers on device development, design control, reliability testing, and cross-functional collaboration with regulatory and QA teams.

You will lead device design concepts, support regulatory submissions, and drive documentation quality while mentoring team members in a matrix organization.

Qualifications

• Minimum degree in Engineering with 5+ years in medical device/pharma development
• Advanced degree (MSc) and 5+ years in medical device industry preferred
• Experience with Design History Files (DHF) and design control processes
• Familiarity with regulatory, QC, cGMP, ISO/ASTM/ICH standards
• Experience with risk management, FMEA and human factors analyses
• Proficiency in device/material selection, design concepts, and manufacturing process optimization

Responsibilities

• Lead development and manufacturing of device components and assemblies in compliance with standards
• Define product requirements for medical devices and drug/device combos
• Oversee studies related to device reliability, quality and documentation
• Support interactions with Health Authorities and regulatory submissions
• Coach team members and coordinate cross-functional sub-teams

Skills

Device design

Regulatory knowledge

Project leadership

Documentation

FMEA/HF analysis

Education

Engineering degree

Advanced degree (MSc)

Tools

SolidWorks

CAD tools

Job description

Lupin Pharmaceuticals Inc. is a specialty pharmaceutical company marketing generic and branded pharmaceutical products as well as Active Pharmaceutical Ingredients (APIs) from its sales and marketing headquarters in Baltimore, MD.

Lupin Inc. has established a new Research and Development Center in the US located in Coral Springs, FL. This center will focus on the development of generic and branded pharmaceutical products.

Essential Duties and Responsibilities

• Provide device and primary packaging expertise in a broader cross-functional drug product development organization, leading and coordinating the development and manufacturing of clinical and commercial device components and assembled devices in compliance with the Corporate, government and relevant industry standards, regulations and best practices.
• Provide recommendations on strategies to select device material, developing device design concepts and incorporated technologies, cost-reduction, high-volume manufacturing and streamlining processes.
• Leading the collaboration with internal and external development partners including monitor work progress according to plan, monitor, support and challenge technical development as well as test and verification work.
• Leading the definition of product requirements for medical devices and drug/device combination products.
• Design, plan, perform, interpret, report results of studies related to development and related processes and procedures of medical devices with a main focus on reliability testing, quality and documentation.
• Develop efficient and robust devices and processes for the manufacture and/or analysis of Medical Devices/Combination Products, risk management activities, evaluating and challenging technical solutions.
• Leading and monitoring documentation work and the development of a high quality Design History Files (DHF).
• Leading and monitoring human factors studies and activities.
• Support Regulatory Affairs to prepare Medical Device/Combination Product pre-registration documents and provide input to answer Health Authority questions. Lead or support interaction with Health Authorities and various medical device industry governing and accreditation bodies.
• Furthermore, support/coach of team members, participation in project(s) sub-teams and contribution to overall strategies and goals.

Qualification and Experience

• Minimum: relevant degree in Engineering and at least 5 years experience in a similar area with continuing education (EU) or BSc or equivalent.
• Highly Desirable: Advanced degree in a scientific or relevant discipline (MSc or equivalent) and at least 5 years’ experience in medical device industry and pharmaceutical development experience.
• Prior experience with dry powder inhalers (DPI), metered dose inhalers (MDI), nasal sprays and nebulizers preferred.
• Successfully demonstrated expertise in medical devices area.
• Mechanical Engineering in general, especially experience in product design, injection molding of plastic components, testing and verification tools, equipment building and qualification desirable. Proficient in utilization and qualification of special tools/equipment for force measurement and metrology.
• Additional background in Electrical Engineering and Material Sciences a plus.
• Experience with development and documentation of medical devices and drug product combination products, including Design Control process and development of Design History File(s).
• Experience with applicable regulatory, QA, cGMP and industry best practices (ISO, ASTM and ICH standards).
• Experience with conducting FMEA, FMECA and Human Factors Analysis.
• Experience with software tools required in medical device industry (e.g., Solid Works, CAD etc.) in addition to general software and computer tools.
• Ability to work in and/or lead teams.
• Leadership and advanced coaching skills. Ability to work in a matrix organization.
• Very good communication skills. Good presentation skills and scientific/technical writing skills.

Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.