KP Recruiting Group is a consulting firm that providesleadership and exceptional talent to some of the world’s leading companies.Headquartered in the Midwest, KP Recruiting Group has successfully completedcountless engagements in the United States, Europe and Latin America. Werepresent clients in all industries and all sizes. Our mission is to provideexceptional client and candidate experiences in order to get the best possibleresults. On behalf of our client, we are excited to present the following confidentialrole. We look forward to hearing from you and discussing the opportunity!

The Role:

The Senior Manufacturing Engineer is expected to provide independent technical contributions, while demonstrating team leadership; the associate will deliver on project management responsibilities in multi-disciplinary teams.

Essential Duties and Position Responsibilities: 

• Plans and manages development of manufacturing activities for legacy products

  • Establishes and drives technical project plans and schedules

  • Leads technical process reviews

  • Satisfies design control documentation, risk assessment, and procedural requirements.

• Coordinates technical aspects related to the maintenance and commercialization of changing medical devices and their manufacturing process

  • Works with Finance and Marketing team to capture and develop project financials

  • Collaborates with Procurement and Planning organization to assure consistent and reliable supply-chain

  • Constructs manufacturing line design, process flow mapping, and capacity analysis

  • Estimates project expense and capital needs and implements expenditures

  • Optimizes product Cost of Goods and Services (COGS) to achieve financial targets

  • Conceptualizes and develops manufacturing methods and process

  • Coordinates process qualifications, validations, and reports (IQ/OQ/PQ)

  • Coordinates and conducts material and process characterizations

  • Coordinates equipment installation and implements Preventive Maintenance procedures

  • Coordinates packaging and labeling validations

  • Organizes with key stakeholders in Quality, Regulatory, Sterility Assurance, Biocompatibility and other specialized functional groups during project planning activities and execution.

• Technical and other responsibilities:

  • Implements and refines product traceability matrices and identifies design inputs

  • Implements and refines Failure Mode and Effects Analyses (FMEA); characterizes and understands acceptable risk; implements risk mitigations, as necessary

  • Provides design input and/or directly designs fixtures, gauges, and equipment

  • Quantification of process input/output using Design of Experiments (DOE) and other analytical methods

  • Problem solving using Root Cause analysis; Define Measure Analyze Improve Control (DMAIC) strategies.

  • Support Corrective Action Preventive Action (CAPA) investigations and responses

  • Measurement validation: using Gauge Repeatability and Reproducibility (GR&R) assessments, Measurement System Analyses (MSA) and equivalent

  • Refines and defines product specifications

  • Competently develops / refines tolerancing of manufactured components

  • Responsible for updates to Design History Files (DHF) and Design Master Record (DMR)

  • Coordinates and implements design verifications and validations, as needed

  • Generates change control documentation to support changes on existing products.

  • Leads and participates in Root Cause Analysis and investigation

  • Generates Standard Operating Procedures (SOPs), manufacturing procedures, and is familiar with GMP regulations

  • Demonstrates proficiency in the application of various manufacturing process, such as Milling, Turning, Grinding, Molding, Forging, EDM, Metal and Plastic Injection Molding, assembly, additive manufacturing, etc.

  • Generates capability analyses and identifies / optimizes sources of variation

  • Identifies and completes cost improvement opportunities

  • Understands and drives Lean manufacturing techniques

Requirements

• Lean Manufacturing experience / training

• Six sigma Training / Certification

• Project Management Training/Certification (PMP/ PMEx)

• Geometric Dimensioning & Tolerancing (GD&T)

• Material science /polymer science / metallurgy experience

• CAD and 3D modeling experience (SolidWorks preferred)

Education and/or Experience:

• Bachelor’s Degree in relevant subject, 10 years’ progressive engineering experience with medical devices or combination devices.

(or)

• Master’s Degree in relevant subject area with a minimum of 7 years’ progressive engineering experience with medical devices or combination devices.

Benefits

Ourclient offers a comprehensive benefits package including:

401kMatching

Family andIndividual Insurance Packages (Health, Life, Dental, and Vision)

Paid TimeOff & Paid Holidays

Long &Short-Term Disability

IdentityTheft Plans

Retirement& Pension Plans

EmployeeAssistance Program

EmployeeReferral Program

TuitionReimbursement Programs

Advancement& Professional Growth opportunities 

ParentalLeave

& More