1 day old

Manufacture Engineer Manager

Handicare USA, Inc.
St Louis, MO 63103
Position Description


Position Title: Manager-Manufacture Engineer 


Department: Research & Development  


Location: St Louis, Missouri


Reports to: Director R&D


 


1. Position Summary


The primary purpose and function of the position is to provide Handicare s Engineering and Product Design team with project leadership, innovative design, project cost control and reliability testing/accreditation.  The position will also provide support to ISO 13485 Quality System of Handicare STL facility


Engineering:


               Act as a doer leader to execute support and manage following activities.


Design and develop new accessories and solutions to support existing products.


Coordinate with Engineering team and Manufacturing in a role of existing product support


Coordinate the purchasing of Prototypes, raw materials, and products to assist in sustaining engineering activities.


Coordinate sustaining engineering project schedules.


Assemble and test prototype systems in both laboratory and working environments.


Assist with the development of fabrication, assembly, and manufacturing processes of the developed devices.


Write proper design documentation as required by the QA product development procedures.


Liaise with Manufacturing department on product improvements, manufacturing efficiency. 


Coordinate Engineering projects that have been outsourced to suppliers or consultants. 


Support the Engineering Change Request (ECR) and Engineering Change Notice (ECN) processes.


 


1.1 Quality System Coordination  


Coordinate the implementation of Handicare s quality system especially as related to Engineering Changes and Product Records


Coordinate QOPs of Handicare s ISO system with focus on Engineering, and Quality Assurance


Coordinate QOPs of Handicare s Complaint Handling System with focus on Product Warranty, MDRs, and Product Life-Span Reliability


 


2. General Requirements


2.1 Skill Set, Knowledge, and Expertise


Experience managing projects (engineering, manufacturing, etc.). 


Sound knowledge and understanding of mechanical, electronic technologies and manufacturing assembly processes.


Sound knowledge and understanding of quality systems, ISO, and quality control procedures. 


Computer literacy especially MS office.


Good understanding of Design FMEA, drafting standards and GD&T an asset.


Proficient in Fast learner who can work with incomplete information and with minimal supervision.


 


2.2   Physical requirements


The employee may occasionally stand, walk, stoop, kneel or crouch during shift.  Employee will be required to regularly sit, use hand to finger, handle, feel and reach with hands and arms.  Employee must be able to occasionally lift, push, pull and or move up to 50 lbs.


Occasional travel to the field less than 5%. 


This position works in an environment with moderate noise levels.


 


2.3 Education Requirements/Work Experience


2.3.1 Required


Bachelors degree in Mechanical / Mechatronics/Biomedical Engineering, or equivalent


7+ years of hands-on experience in mechanical and systems design


5+ years of experience with 3D solid modeling CAD (preferably SolidWorks 2016 or above) 


 


2.3.2 Highly Beneficial


Knowledgeable of the following standards: ISO 10535:2006, IEC 60601, ISO 13485, ISO 14971


Experience in the design, development, and testing of medical devices


Experience in risk assessment methodologies


Experience in user-focused design and consumer products


Experience in Good Manufacturing Practices procedures


 


3. Behavioral Competencies. 


Attention to detail demonstrate mastery of the many details and finite elements involved with managing engineering projects, in ISO/GMP quality system.


Teamwork and co-operation works effectively with other departments, shares knowledge and experience.


Achievement continuously improves personal and corporate performance.


Organizational commitment-actively supports the organization.


Initiative acts preemptively solve problems.


Flexible adapts to different challenges and enjoys multi-tasking.


 


4. Supervisory Responsibilities. 


This position will be supervising 2-3 Manufacturing Engineers.


 


 


Handicare is looking for a person who enjoys solving technical problems within a fast-paced environment while following the quality development processes that are essential to the creation of medical devices and applications. While the work is plentiful and challenging, the atmosphere is very friendly and relaxed; a sense of humor is always appreciated.


EOE/M/F/D/V


Note: Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.  Critical features of this job are described under various headings above.  They may change at any time due to reasonable accommodations or other reasons.  The above statements are strictly intended to describe the general nature and level of the work being performed.  They are not construed as a complete list of all responsibilities, duties and skills requires of employees in this position.   The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


I have read and understand the duties of my position:


 


Print Name: _____________________________________ Date: ___________________________


Signature: _______________________________________


 

Categories

Posted: 2021-09-26 Expires: 2021-10-26

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Manufacture Engineer Manager

Handicare USA, Inc.
St Louis, MO 63103

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast