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Engineer
Job Description
*depending on experience
This role will be required to:
Plan and author technical documentation, including test plans/protocols/reports and a variety of engineering assessments.
Perform hands on testing of autoinjector devices, including the safe operation of test equipment and devices containing sharps (syringes).
Analyze and report data, along with any recommendations, to a variety of stakeholders.
Provide technical input for mechanical problems to programs as needed.
Plan and execute tolerance and robustness analysis of complex mechanical designs.
Use project planning to monitor and track project deliverables to ensure accurate completion.
Collaborate with cross-functional teams to ensure adequate sustainment and improvement of products throughout their lifecycle.
As part of the team working on device platforms, ensure alignment of documentation to support variants and combination products.
Basic Qualifications
B.S. in Engineering or Scientific Discipline
Effective Communicator (Oral/Written)
Technical Writing (Protocols, Reports, Technical Assessments, Presentations)
Preferred/Demonstrated Competencies
Broad set of knowledge and expertise in contributing to complex, multi-disciplinary and cross-functional product development efforts
Experience in drug/device combination product design, and development
Background in development, commercialization, and lifecycle management of medical devices
Physical test method development, qualification, and validation
Experience executing lab tests, including safe and proper operation of lab equipment (Instron tensile tester, Keyence inspection equipment, manual and automated autoinjector testing, CT scanner etc.)
Experience conceptualizing, designing, and building test fixtures
Technical understanding of drawings including tolerance stacks and robustness analysis
Knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position
Familiarity with the following standards: US Good Manufacturing Practices (21CFR820), Quality Management (ISO 13485), Risk Management (ISO 14971), EU Medical Device requirements (Council Directive 93/42/EEC), Needle Based Injection Systems (EN ISO 11608-1), and Medical Electrical Equipment (EN 60601)
Knowledge of dFMEA/pFMEA
Capable of working on multiple projects in a deadline driven environment
Strong oral and written communication skills, decision making, presentation, and organization skills
Ability to collaborate with other disclines within the technical team such as, systems engineering, design engineering, human factors, MSAT, packaging engineering and other functions e.g., drug product, drug substance and product quality.
Demonstrate ability to navigate ambiguity and provide a structured problem-solving approach
Track record of building or participating as a member of successful teams
Working knowledge of MS Office tools, Solidworks, Minitab or JMP and Smartsheet
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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