Sr. Manufacturing Engineer

Biomerics•Brooklyn Park, MN

23h

About The Position

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries, specializing in designing, developing, and producing medical devices for diagnostic and interventional procedures. The company focuses on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets. Biomerics is dedicated to its diverse employee base, valuing integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence. The Senior Manufacturing Engineer will provide manufacturing support for existing products as well as develop and introduce new products and equipment.

Requirements

Bachelor’s or Technical Degree in related engineering field (Mechanical or Industrial) preferred or minimum 5+ years’ experience in a medical device manufacturing environment.
Possess a broad, in-depth knowledge of manufacturing processes and systems and is able to apply appropriately
Work independently and develop manufacturing systems including processes, tooling, automation, and controls.
Ability to effectively execute high level engineering tasks including planning, scheduling, and leading major cross-functional technical projects of a complex manner
Intuitively identifies technical risks and acts proactively to reduce negative impact on product and projects
Effectively provide guidance to junior Engineers and technical personnel.
LEAN manufacturing experience
Experience/knowledge with process and equipment validation, PFMEA , IQ/OQ/PQ
CAD experience/knowledge
Must possess good project management skills and initiative in taking on and completing projects
Must possess good verbal and written communication skills

Nice To Haves

Bachelor’s or Technical Degree in related engineering field (Mechanical or Industrial)

Responsibilities

Design and develop manufacturing procedures, tooling, and fixtures that result in sufficient capacity to meet customer demand while promoting product quality, process efficiency and operator safety.
Provide production line support, including but not limited to implementing process improvements, troubleshooting equipment, and addressing operator inquiries.
Generate and modify manufacturing process documentation. Assure that manufacturing processes and related documentation follow established policies and procedures.
Utilize LEAN, Six Sigma, and other best practice tools and principles for day-to-day problem solving and continuous improvement.
Assist in identifying equipment needs on the production floor and evaluate internal and external options for sourcing such equipment.
Generate and modify component and assembly drawings using Solid Works.
Develop and release new products using customer or internal specifications.
Write and execute process and equipment validations (IQ/OQ/PQ).
Work with Research and Development, Marketing, Quality, and Manufacturing Departments during concept, prototyping, and release of new products.
Work with Internal Audit team to perform annual schedule of quality system audits.
Work with external vendors as needed.
Perform equipment maintenance by following manufacturer’s instructions and established procedures.
Other assignments as requested.