Manager Manufacturing Engineer
Full Time. Louisville, CO
Bolder Surgical is seeking an experienced Manager of Manufacturing Engineering who has excellent technical judgment and understands customer focus from product concept to full-scale production. In our environment, leadership, hands-on technical skills, and working well across the organization is a must to innovate solutions that meet market needs, organizational objectives, and project goals.
Reporting to the Head of Operations, you will grow and lead a Manufacturing Engineering team, building a technically strong, innovative, and collaborative team.
In this position:
- You and your team will develop and execute product and process improvements to improve quality, increase yield, reduce costs, and enable rapid scaling of production volumes.
- You and your team will work within the product development teams providing input to the product design to promote manufacturability and assembly processes.
- You will lead our contract manufacturers and component suppliers to bridge from development to manufacturing.
- You will partner with product development engineers to execute an effective pilot production strategy and manage the sustaining process.
- You and your team will provide technical support to in-house and contract manufacturing sites, ensuring continuous manufacturing of products to meet current commercialization demands.
- You will overcome challenges, identify opportunities, and help lead the team through project completion and transition to a stable manufacturing environment.
- You will contribute to our entrepreneurial culture by adding your style and strengths to ours.
This position is responsible for the following:
- Initiate, manage and implement product design and manufacturing process improvement projects.
- Initiate, design, implement and take ownership for effective medical device pilot production
- Initiate and lead the development of new product manufacturing to identify and implement in-house and contract manufacturing processes, assembly fixtures, and test
- Recruit, mentor, and manage a Manufacturing Engineering team.
- Create a culture of collaboration between R&D and Operations while developing internal processes to transition new products or processes from concept into manufacturing.
- Work with the core product development team, manufacturing team, contract manufacturers, and component suppliers to develop manufacturing processes and adjust the design, dimensional, and material specifications to optimize the design for manufacturability and assembly.
- Select, qualify, and validate new and existing supplier processes.
- Understand manufacturing and product development challenges, use critical thinking skills and technical judgment to troubleshoot, and maintain
- Build, test, and evaluate the product and processes as needed for project or production deliverables.
- Lead and develop all component qualifications.
- Bachelor’s degree in Mechanical Engineering or related engineering discipline.
- 10+ years of significant experience in product development, advanced manufacturing, or operations, preferably in a leadership
- Experience in leading teams and projects in a manufacturing and/or product development role, preferably cross-functional.
- Experience managing and working with suppliers to develop, enhance, and qualify manufacturing processes for components.
- Experience with a wide range of materials and manufacturing processes used in medical device manufacturing.
- Experience in prototyping and testing complex electromechanical assemblies and fixturing.
- Possess significant experience with production to include defect and failure analysis at the functional, component, and assembly
- Possess flexibility, finding creative solutions to effectively resolve component or process deviations while maintaining customer and product specifications.
- Strong critical thinking skills, with the ability to anticipate issues, quickly establish backup plans, and present ideas and concerns to the team and the broader organization.
- Know Medical Device Risk Management procedures and documentation requirements.
- 75k – 120k (Salary to be determined by the applicant’s education, experience, knowledge, skills, and abilities, as well as internal equity and alignment with market data.)
- Equity Participation
- Medical, Dental, Vision
- Life and Disability insurances
- Paid Time Off and Paid Holidays
- Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA)
- 401K retirement savings plan
- Parental Leave
- Voluntary Life Insurance for employees, spouses, and children
- Voluntary Critical Care and Accident Insurances for employees, spouses, and children
- Tuition Reimbursement
- Referral reward bonuses
- Corporate discounts
- Employee Assistance Program
Work Environment/Other Information
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to work flexible hours.
- The employee is regularly required to sit, stand, walk, and reach with hands and arms, use hands to finger, handle, feel, and be able to talk and hear. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.
Bolder Surgical is a medical device manufacturer based in Louisville, CO that has redefined surgery particularly in small spaces. Founded in 2010, we have developed and are marketing laparoscopic surgical instruments including the world’s smallest low-power 3mm Vessel Sealer & Generator and the world’s first ever 5mm linear Stapler. As the company continues to bring unique, high quality products to market, activities around R&D, quality, regulatory, sales, marketing, and manufacturing are increasing dramatically. The company is well capitalized and is poised for substantial growth through the coming years.