Someone who has a experience in medical devices and/or combination products. At least 5 years of experience. Someone proactive and independent and can work at a fast pace.
This role will support project teams in the design, development and life cycle management of drug delivery devices. This includes technical operations support for design control activities, contract manufacturing, failure investigation, leading and assessing design changes, development of test procedures, scale-up, and continuous improvement.
Scope includes mechanical and electro-mechanical delivery devices such as fluid transfer devices, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of the mechanical and electro-mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as developing product enhancements, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.
Work cross-functionally with individuals and within project teams to provide technical assistance to projects.
Develop and maintain technical records within design history file associated with assigned products.
Develop test methods, generate and maintain design specification, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, design transfer, etc.
Support system level root cause investigation, design improvements with development partners, strategic planning and execution of design changes and improvements.
Work with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
BS in Engineering (Mechanical / Industrial / Biomedical) and previous experience in a medical device, or similar industry, with 5 - 10 years current experience with engineering processes and procedures.
Strong background in engineering of electro-mechanical and disposable medical devices and combination products.
Ability to model and analyze mechanical systems, fluid flow, stress, assemblies, structures, linkages, heat transfer and other mechanical engineering specialties.
Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
Familiarity with the following standards:
o 21CFR820 Quality System Regulation
o ISO 14971 Risk Management
o EU Medical Device requirements
o Medical Devices Directive 93/42/EEC
o Medical Electrical Equipment
o EN 60601
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Strong problem solving, risk assessment, and risk management skills.
Must be capable of working on multiple projects in a deadline driven environment
Top 3 Must Have Skill Sets:
BS in Engineering (Mechanical or Industrial or Biomedical).
Previous experience in a medical device, or similar industry, with 5 - 10 years current experience with engineering processes and procedures.
Expertise in technical documentation (protocol & report writing), design verification & validation, FMEA, design transfer, root cause investigation, design improvement and product optimization, etc.
This role will start out remotely and then will go onsite, M-F