Sr Manufacturing Engineer

• Execute manufacturing activities for in-house and contract manufacturing including supplier/CM relationships to ensure builds meet product plans and quality/regulatory requirements.
• Partner with Supply Chain to align raw material/component availability to build schedules; track and be accountable for material issued to production/projects.
• Develop and maintain manufacturing and packaging/labelling processes specifications and documentation (e.g. MPIs LHRs packaging work instructions/specs BOM/configuration labelling requirements) in collaboration with R&D Quality Regulatory and Marketing; support establishment of manufacturing line readiness and contribute to DCOs for manufacturing engineering.
• Support and execute product/process development and transfer activities including prototype builds time studies manufacturability improvements and cost/yield optimization to support smooth transition into manufacturing and achievement of cost targets.
• Engage and support verification/validation activities with Quality/RA/R&D including manufacturing IQ/OQ/PQ and packaging validations (e.g. sealing/process validation package integrity distribution simulation shelf-life/aging) including protocol execution support data review and report inputs.
• Define in-process inspections and testing with Quality; troubleshoot manufacturing packaging printing and labelling issues (e.g. barcodes/variable data print quality adhesion/legibility handling/shipping damage) and implement corrective actions through structured problem solving and continuous improvement.
• Determine procure and verify tooling fixtures and equipment; plan equipment/workflow layouts; manage equipment design/development and coordinate calibration and preventive maintenance in conformance with the Quality System.
• Contribute to cross-functional project execution from early concept through clinical testing by developing and maintaining project schedules executing assigned tasks and ensuring timelines/budgets are met; participate in team meetings and maintain positive working relationships.
• Conduct methodical root cause investigations and provide guidance to prevent recurrence.

• Bachelors degree in engineering or related discipline and a minimum of 5 years of related experience; or equivalent combination of education and work experience.
• Demonstrated knowledge and experience in pilot/production line setup and validation in controlled environment including work under quality systems designed to meet governmental regulations such as FDA QSR ISO 13485 and the MDD.
• Ability to detail project plans effectively.
• Familiar with GMP GDP procedures and requirements.
• Excellent communication skills (both written and verbal) required.
• Ability to work independently or in team setting required.
• Must be able to travel.
• Experience with problem solving methodologies like Six Sigma and/or Root Cause Analysis.
• Experience supporting medical device packaging and labeling activities in a regulated environment including packaging/labeling documentation issue troubleshooting and packaging/labelling verification/validation deliverables preferred.
• Certified Six Sigma Yellow Belt or Green Belt preferred.
• Project management experience preferred.
• Catheter manufacturing or medical device experience preferred

The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.

Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.