Medical Engineering Consultants (MEC) · 13 hours ago
Process Development Engineer
Medical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing resources and expertise. They are seeking a highly motivated Process Development Engineer to lead the commercialization of new products and process improvements, focusing on developing processes from concept to production.
ConsultingMedical DevicePharmaceuticalTraining
Responsibilities
Assess process capabilities, prioritize process improvement opportunities and innovate and implement process improvements on complex projects
Apply technical knowledge to innovate, design and develop processes, procedures, tooling and/or automation
Execute the functional deliverables associated with the PDP/TDP Project Management and Quality Systems
Own/contribute to technical reports, validations and qualifications by capturing experimental results
Ensure visibility and closure of process issues e.g. yields, cost, capability etc. per PDP milestones
Evaluate external technologies and strategically identify opportunities to implement them internally
Evaluate emerging technologies and develop strategic roadmaps for internal adoption including business case development risk assessment and implementation planning
Contribute to projects, manufacturing technology, strategy
Write and review validation protocols and reports applicable to new processes
Serve as a key contributor and participant in technical reviews, preparing and presenting technical data and recommendations at technical and business reviews
Provide Design for Manufacturability (DFM) input to the engineering print package
Partner cross-functionally to develop design specifications, test methods and material selection
Contribute ideas to or generate Intellectual Property submissions
Train and/or provide work direction to technicians and may train manufacturing personnel when required as part of prototype line development and validation
Qualification
Required
Bachelors degree in engineering
4 years of professional engineering experience relevant to this role, Product/Process Development, Manufacturing etc
Excellent communicator
Collaboration and able to work effectively with others/teams etc
Microsoft office - proficiency in excel
Preferred
Bachelors degree in mechanical, Biomedical, Chemical or Electrical Engineering
Hands-on mechanical aptitude
Demonstrated engineering fundamentals (LEAN, DFM, Six Sigma etc.)
Demonstrated cross-functional teamwork in a technically demanding environment
Strong conflict resolution and problem-solving skills
Strong written and verbal communication skills
Prior experience with medical device industry or similar highly regulated industry
Company
Medical Engineering Consultants (MEC)
MEC is a comprehensive solution provider with a full suite of services from consulting and contracting to training and cost savings initiatives.