Sr. Manufacturing Engineer

SUMMARY:

Our Implantables & Consumables division is a leading contract manufacturer for medical and combination devices. We work side-by-side with our customers in the development of the manufacturing process of new products. During the multi-year relationship with our customers, we increase manufacturability by implementing custom automation designed and built in-house, produce batches for testing phases, and ensure compliance with all regulatory bodies required for the production of Medical Devices, Combination Devices, and Pharmaceuticals.
As a Manufacturing Engineer you will aide in streamlining our manufacturing process. Our ideal candidate will have a passion for manufacturing with a background in medical device, pharmaceutical or regulated manufacturing industry experience.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Assist in the development and qualification of Medical Device and Industrial productions
Evaluate manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators.
Develop manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.
Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
Assure product and process quality by designing testing methods; testing finished goods, determining product and process capabilities; establishing standards; confirming manufacturing processes.
Provide manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.
Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
Provide manufacturing engineering information by answering questions and requests.
Maintain product and company reputation by complying with FDA and ISO
13485 regulations.
Keep equipment operational by coordinating maintenance and repair services; following manufacturer‘s instructions and established procedures; requesting special service.
Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
Apply FMEA process to evaluate failure data, if necessary, from field data to find root cause and implement sound engineering solutions.
Support validation in all manufacturing processes per FDA requirements for medical equipment.

QUALIFICATIONS:

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
A Bachelor of Science in Engineering.
A minimum of 2 years of experience as a Manufacturing Engineer
Medical device, combination device, pharmaceutical, or other regulated product manufacturing experience.

Experience with Lean Manufacturing and Six Sigma principles including DMAIC, The 5 Why‘s, 5S, Value Stream Mapping, Regression Analysis, FMEA, Kaizen, Gage R&R, etc.

Experience with Root Cause & Corrective Action principles.
Strong written and verbal communication skills in the English language.

Experience with MS Windows operating system and products.
Experience in applying advanced mathematics, and algebra skills.

Experience with automated production lines is preferred.