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; Ppareto rejects, filter key inputs to process to generate a DOE. Design and execute optimization DOEs.
• 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

REQUIRED: 

• BS degree in Engineering discipline (Biomedical, Manufacturing, Mechanical, Industrial, Operations Research, etc.)
• 3 years of experience in regulated medical device or pharma industry

Skills: 

• 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

Preferred: 

• Master of Engineering
• MBA
• PMP
• 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