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Device Engineer
Job Description
Target PR Range: 30-40/hr
*Depending on experience
Ideal Candidate: has hands-on experience in engineering environments, particularly with tools like Instron systems and optical measurement methods, as well as proficiency in technical documentation and teamwork. They should have experience in regulated industries, preferably biopharma, biomedical, or medical devices, though aerospace or mechanical disciplines are acceptable. Proficiency in Microsoft Office is required, and CAD/SolidWorks skills are a plus. Entry-level candidates with practical experience, such as internships, are preferred, while overqualification (e.g., PhD or advanced degrees with extensive experience) is less desirable. Packaging engineering knowledge is a bonus but not mandatory.
Job Description
The Device Engineer will participate in the design, development, and lifecycle management design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.
Scope includes mechanical delivery devices, such as; Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, defend inspection and ensure the follow through of commitments.
Essential skills and Responsibilities:
• Adheres to strict documentation practices in a GMP regulated environment
• Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.
• Authors and reviews technical documentation including protocols, reports, and technical assessments
• Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
• Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
• Maintains combination product design history files for assigned products
• Develops characterization test methods through fixture prototyping, reference sample creation, and GR&R analysis
• Provides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessments
• Provide general laboratory support including inventory management, sample shipments, and cleanup.
• Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications
• Individual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organization
• At a minimum familiar with the following standards and regulations:
• Quality System Regulation – 21CFR820
• Risk Management – ISO 14971
• EU Medical Device requirements – Council Directive 93/42/EEC
Preferred Qualifications:
• Bachelor’s Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
• Minimum 2 year of scientific or engineering experience in a GMP regulated environment
• Statistical Analysis software (Minitab or JMP)
• Strong technical writing skills
• CAD fixturing software (SolidWorks)
• Instron force tester using BlueHill Universal
• Experience with design controls; including (but not limited to) verification and design transfer
• Understanding of risk assessments including hazard and probability analysis
• Background in medical device development, commercialization and knowledge of manufacturing processes (fill-finish)
• Ability to work independently and dynamically across functional teams
• Excellent written and verbal communication skills
• Ability to support complex workstreams under demanding timelines
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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