Senior Manufacturing Engineer

Posting Date: 05/09/2019
Closing Date: 07/09/2019
Posting Level: Mid-Level

Wilson Wolf Manufacturing Corporation is a privately held, fast-growing Class 1 medical device company in New Brighton, MN with a staff of about 25 people that invents and makes critical cell culture technology that is enabling the field of T Cell Therapy to provide incredible results for cancer patients. They provide cancer patients with the real prospect of a cure with every device that they deliver.

Due to the high market response to their patented product portfolio, the company is experiencing 100% year over year growth in revenue and product demand. To scale accordingly, the company is implementing the Entrepreneurial Operating System of Traction, expanding into a 50,000 sq. ft. facility, and increasing the size and competencies of its staff.

They have engaged Talencio in the recruitment of a Senior Manufacturing Engineer. They are seeking an individual with a proven history of being a go-to person, routinely making others around them better, taking on hard challenges and making them look easy, and consistently rising to any occasion.


Reasons to Apply:


• You’ll be an instrumental part of a team that will play a critical role in providing society with
widespread access to T Cell Therapy, which many believe is one of the most important
advances in the history of cancer treatment.
• Wilson Wolf is highly profitable with no debt, and its liberal profit-sharing plan has paid out
an increasing amount of money for 4 consecutive years, providing employees at every level
of the organization with substantially higher compensation than they would have the
potential to earn elsewhere.
• This combination of meaningful work and potential for exceptional compensation is a rare
opportunity.
• Wilson Wolf’s founder has a strong track record, having already created two T Cell Therapy
companies with a combined value of $800M, one of which includes the 2018 Nobel Prize of
Medicine recipient.


Position Summary:


The Senior Manufacturing Engineer will play a role in new product development and existing product manufacturing of disposable plastic devices. Activities will include design for manufacturing, establishment and improvement of manufacturing processes and equipment, as well as continuation engineering. The company is currently transitioning from QSR into ISO13485. This position requires a strong track record of successful medical device manufacturing environment, solid interpersonal skills, hands-on capability and exceptional problem-solving skills.


Responsibilities include but are not limited to:


• Interfacing with Product Development engineers with a focus on design for manufacturing.
• Leading the development of manufacturing equipment and processes.
• Overseeing and performing IQ/OQ/PQ activities.
• Generating and conducting Process FMEAs and Process Validations.
• Improving product quality, labor efficiency, and throughput using Lean manufacturing
concepts.
• Coordinating the design, procurement, build and debug of tooling, machinery and test
equipment.
• Working with Product Development to ensure Design for Manufacturability.
• Optimizing existing manufacturing process.
• Performing root cause analysis, document findings and create recommendations.
• Documenting work instructions, technical reports and validations.
• Gathering and providing technical data for technical reviews and decision making.
• Working collaboratively with production assembly operators, engineering staff, and quality to
identify and resolve issues.
• Developing research/verification/validation protocols and reports.
• Developing Product Design History files.
• Investigating proposed process/product changes to assure continued safety and quality
improvements.
• Representing engineering, as needed, in the review and approval of proposed change
orders, deviations and nonconforming material records to determine the effect of the
proposed changes on materials, products and processes.
• Using SolidWorks to develop detailed 3D CAD models and drawings of component,
subassembly and top level drawings to document design concepts, and technical notes.
• Identifying, improving, and communicating documentation or procedural changes that
support the Company’s ongoing desire for continuous improvement.


Qualifications and Characteristics:


• Minimum of a Bachelor’s degree in Engineering.
• Minimum of 8 years solid, hands-on, engineering experience in a medical device
manufacturing environment.
• Experience with moving products from a development state to a final manufactured version.
• At least a general understanding of Quality System Regulations and ISO 13485.
• An energetic, collegial and professional demeanor capable of identifying issues and working
collaboratively to propose and implement solutions.
• Enjoys a variety of work in a fast-paced, startup environment.
• Self-motivated with ability to handle, organize and prioritize multiple tasks.
• Thorough and detail oriented.
• Excellent written and verbal communication skills.
• Capable of communicating effectively at all levels of the organization.
• Proficient with SolidWorks design software.
• Proficient with MS office applications such as Word, Excel, and Adobe Acrobat.


Performance Measures:


• Timely execution of engineering activities and other assigned tasks.
• Customer (internal and external) satisfaction of product and process designs and delivery.
• Involvement in the design process, implementing a vigorous approach towards anticipating,
preventing and correcting design problems in manufacturability of products.
• Exhibits professionalism, can-do attitude, makes those around them better, and brings an A
game daily.


To apply, please send resume to amehlhoff@talencio.com.



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