General Manager / Engineering Manager
General Manager / Engineering Manager
Position Type: Direct Hire
Position Location: NW Houston, TX (Relocation Assistance, if applicable)
Position Salary: Open to Market (Depending on Experience) + Bonuses/Incentives
- This position will be in charge of getting the facility up and running and FDA approved for N95 mask production
- Responsible for evaluating progress toward Engineering performance objectives and continuously seeking ways to improve products, services, and processes to increase value for customers.
- Will be in charge of Plant layout and getting machines set up and ready for production
- Expected to have knowledge and full understanding of the complete portfolio of products as well as the market segments that these products are used in.
- Requires the ability to analyze trends, customer operations, organizational challenges, and connect those needs with the portfolio of product solutions and services.
- Require the leadership ability to continually improve team and employee performance, as well as collaborate with employees and leaders from other internal departments, Customers, and external strategic business partners.
- Build & maintain business processes, systems, and documentation; collaboration with Strategic Partners; and leading development of new products.
- Lead the Engineering team to successfully build, maintain, & innovate high quality products that provide solutions that meet or exceed market expected value.
- Ensures, implements, and manages ISO, FDA, and HIPAA requirements related to Engineering and Design.
- Maintains customer liaison/relationships and use modern strategies to develop elegant product solutions for the medical industry.
- Prepare documentation, including but not limited to: business requirements documents (i.e., product specifications), application workflows, wireframe specifications, user manuals, and maintain product knowledge base.
- Review designs, documentation, prototypes, testing, customer support, and modifications for products.
- Responsible for training internal staff on product functionality and maintainability.
- Stay active and engaged with important healthcare related trends and changes that impact our business or clients.
- Maintain understanding of industry standards, best practices, and technological innovations in our segment of the healthcare market.
- Assess clients’ needs, provide workflow analysis, and redesign solutions for inefficiencies in the medication management processes.
- Recognized internally as the product expert for driving reliability, maintainability, availability, and innovation of products
- Bachelor’s Degree in Engineering or equivalent background; Master’s degree preferred.
- 10+ years of documented success in medical device or PPE product development for hospitals and healthcare environments.
- Minimum of 4+ years of documented success leading Engineering teams developing, maintaining, and supporting medical devices for hospitals and healthcare environments
- Extensive theoretical and practical experience in the concept, design, release, manufacture, sustaining, and support of healthcare products.
- Strong ability to lead, coach, and manage software development from problem identification to product release. Ability to manage products from conception to completion.
- Strong organizational and time management skills.
- Strong background with ISO 5 or ISO 7 preferred
- Self-motivated and driven, demonstrable positive attitude.
- Ability to work within a cross-functional team of professionals.
- An attitude to solve problems and manage situations quickly and effectively.
- Experience developing, maintaining, and supporting products for the healthcare market.
- Experience developing products that are compliant with FDA medical device regulations.
- Able to quickly discover & implement the simplest and most direct solutions to challenging problems.
Due to the high volume of applications we typically receive, we regret that we are not able to personally respond to all applications. However, if you are invited to take the next step in the process, you will typically be contacted within 3 weeks of submitting your application