Senior Manufacturing Engineer



Advert ID




Job Type




Salary Range

Based on Experience

No. of Openings


Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435



Job Description


The Senior Manufacturing Engineer will play a lead role in supporting the manufacturing requirements of commercially released products as well as products that are in various stages of development.

Essential Responsibilities:

* Develop manufacturing processes that are capable of achieving design requirements from laboratory through pilot line, into full scale manufacturing

* Create and/or execute, as well as formally document, manufacturing process equipment validations consistent with company requirements and standard operating procedures

* Coordinating efforts to design, develop, and validate manufacturing processes using tools such as Design Of Experiments (DOE), Measurement System Analysis (MSA), Failure Modes and Effects Analysis (FMEA), Statistical Process Control (SPC), and capability analysis

* Develop and/or communicate process/equipment specifications for process/equipment suppliers regarding quotes based on the product and customer requirements

* Engaging and/or leading cross functional teams in Design for Manufacturability (DFM)

* Create detailed project plans and manage the execution of assigned projects

* Develop effective relationships (internally and with suppliers)

* Communicate and manage through adversity-both internally and with suppliers

* Work closely with a broad and diverse range of customers including pharmaceutical companies and process equipment suppliers to ensure that the company manufacturing process/equipment requirements are meet, as well as to ensure a deep and current understanding of the customers/markets served

* Bring forward and deploy best practices in manufacturing engineering excellence

* Ensure integrate approach/process with device design, process/equipment suppliers, and other strategic partners in the business

* Deliver results: support commercial manufacturing, support assigned product development projects from a manufacturing perspective, and take a lead role in striving to achieve manufactural products that have high quality and robust manufacturing processes in collaboration with Product Development / Quality / Suppliers


* Bachelor's degree in Engineering or technology related field required. Master's Degree in Engineering or Business preferred

* Six sigma black belt preferred

* Minimum of 5 years medical device background with experience in injection molding

* Minimum of 5 years' experience manufacturing process development including:

* Characterization, process optimization, validation, and ramping production for high-volume specifications in the medical device industry

* Proven ability to write thorough technical protocols, plans, and reports

* Experience creating and writing process/equipment IQ/OQ/PQ validations, including test method validations

* Experience executing process/equipment IQ/OQ/PQ validations, and documenting such in written final technical reports

* Experience working with a variety of assembly, plastic injection molding, and machining suppliers

* Experience with equipment and tooling designs including machine specifications

* Experience supporting/representing the manufacturability/manufacturing processes for commercially approved products; as well as products that are in various stages of product development but planned for future commercial release

* Knowledge related to regulatory requirements for GMP

* A solid track record of completing successful manufacturing projects, on time and within budget