We are looking for a Component Engineer to join our client in Danvers, Ma.
As a member of the contract manufacturing team, drive pre-market operational excellence in development projects involving contract manufacturing partners through effective partnership with external suppliers and internal cross functional teams to assure that our products meet/exceed quality/service/cost/compliance expectations upon launch.
MAIN JOB DUTIES/RESPONSIBILITIES
- Support Engineering team on PDP projects, product transfers, CM conversions, cost saving and material replacement projects.
- Determines specific requirements of manufacturing operation to specify equipment, fixturing and process parameters.
- Continuous improvement and cost analysis. Identify, evaluate and implement opportunities for improvement in manufacturing processes.
- Lead DRM/improvement projects, both proactive and reactive
- Provide engineering support to contract manufacturing operation.
- Lean and Six Sigma understanding; ability to time study, calculate Takt time, line level;
pareto rejects, filter key inputs to process to generate a DOE.
- Utilize basic statistical methods to support engineering testing.
- Compare internal yield/external complaint failure model with the process FMEA and accurately assess quality impact.
- Lead engineering projects intended to replace obsolete materials, validate process changes, or implement machinery upgrades/replacement.
- Tasks including: Project management deliverables; protocol generation; report generation; supplier interactions; technical assessment of changes; and risk review.
- Process change orders or supplier change orders in configuration management software (AGILE).
- Create purchase orders in purchasing software.
- Lead supplier audits and drive First Time Quality events to reduce risks
- Use Design Reliability Manufacturability (DRM) methodology to improve product quality and reliability:
- Understand production lines- asses risks, audit, how cell is aligned, lean maturity
- Ability to work with cross-functional design teams. Be the voice of ops to explain implications of design changes on regulations and lines
- Ability to understand design print creation and finalization, tolerances,
- Establish reliability & predictive capability of process and components
- Requirements flow down and tracing design outputs to inputs
- Design of Experiments (DOE)
- Deploy Lean and Six Sigma methodologies to ensure strong root cause investigations
- Use Cell Operating System methodologies to drive operational excellence of work flows
- BS degree in Engineering discipline (Biomedical, Manufacturing, Mechanical, Industrial, Operations Research, etc.)
- 3 years of experience in regulated medical device or pharma industry
- Team dynamic skills (communication, accountability, decision-making, feedback, meeting management, managing conflict).
- Virtual interaction with teams
- Computer literate
- Statistical skills
- Knowledge of statistical software.
- Technical writing skills
- Verbal, written and presentation skills
- Project management skills
- Working with suppliers supporting produce development on pre-market products (focus on components and subassemblies
- Master of Engineering
- 5 years of experience
- Experience in an ISO13485/GMP environment preferred.
- Engineering experience with disposable medical devices also preferred.
- Six Sigma, Constraint Management and Lean Manufacturing experience preferred
- Supplier Auditing experience/certification
- Strong Relationship building skills
- DOE, SPC, FMEA, GMP, QSR
- Knowledge of materials and related processes