Manufacturing Engineer II in Danvers, MA at Apex Life Sciences

Date Posted: 5/16/2018

Job Snapshot

Job Description


For immediate consideration, please send an up-to-date version of your resume to jhambrose@apexlifesciences.com

Sr. Manufacturing Engineer

A Day in the Life
In this Senior Manufacturing Engineer role, you will be developing manufacturing methods, systems, equipment and processes on existing products to produce a high-quality product at optimal cost.

Responsibilities include, but are not limited to:

  • Develop and implement process improvements that improve cost, quality, delivery and safety.
  • Design and develop equipment and fixtures to improve process and support lean manufacturing through collaboration with external vendors or internal equipment department.
  • Develop and execute plans, including statistical analysis, to evaluate process repeatability through equipment qualification and process validation (IQ/OQ/PQ).
  • Provide engineering support to manufacturing operation and address quality issues arising on the production floor.  Form and lead cross-functional teams to resolve high profile production issues and document recommended corrective actions using the quality systems procedures. (NCMR & CAPA). 
  • Improve manufacturing methods, optimize product performance and reduce manufacturing costs through Lean 6 Sigma methodology.
  • In partnership with Finance, perform cost analyses of proposed manufacturing changes
  • Define and generate all required documentation in support of manufacturing protocols, reports, changes and manufacturing instructions. These include:  Engineering protocols, reports, process risk documents (PFMEA), manufacturing instructions, change orders and statistical analysis.


Must Haves - Minimum Requirements

  • Bachelor of Science Degree in Engineering
  • 6+ years of experience in manufacturing environment (2+ years in a medical device manufacturing)
  • Experience with equipment development and process validation (IQ/OQ/PQ)

Nice to Have

  • Small tooling design and development
  • Project management experience
  • Engineering experience with disposable medical devices
  • Knowledge of polymer materials and related processes
  • Design of Experiments (DOE)
  • Electro-Mechanical troubleshooting skills
  • Verbal, written and presentation skills
  • Technical writing skills
  • Microsoft Project 
  • Strong statistical skills using Minitab
  • Six Sigma Lean Manufacturing experience
  • Team dynamic skills (communication, accountability, decision-making, feedback, meeting management, managing conflict).
  • Problem solving and root cause analysis for improvements or non-conformances

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.