This Scope of Work (SOW) will provide details regarding an Operation Integration engineer role that is required to support an upcoming new product introduction, Project Defender.
Project Scope
The goal of project Defender is to develop and commercialize the next generation disposable Negative Pressure Therapy (dNPT) system for civilian and military use. The project will be initiated in Q2 2024 and will require design and development of electro-mechanical devices and soft goods intended for clinical use.
Job Description
Requires a fulltime Operations Integration / Manufacturing Engineer for a contract of one calendar year with the option to extend in quarterly increments. The role will require the following but is not limited to:
Development of engineering Bill of Materials (BOM) in ERP management software
Identifying and quoting manufacturing methods with suppliers
Identifying and quoting new materials, and components with suppliers
Monitor ordering and receipt of materials
Coordinate shipping of engineering parts (i.e. sterilization, test houses, etc.)
Material intake, inspection, and documentation
Managing trade compliance activities
Coordinate engineering and production builds
Identify process steps and drafting manufacturing work instructions
Draft build requests and developing protocols with manufacturing facilities
Develop, review, and approve design control, compliance, and process documentation
Role will require up to 20% travel to San Antonio office or international manufacturing facilities (if not collocated)
Minimum Qualifications
The minimum qualifications for this role include the following:
bachelor's degree in an applicable engineering discipline such as mechanical, electrical, or biomedical engineering.
Experience with MS Office suite
Candidate must be located within the contiguous United States.
Preferred Qualification & Experience
Preferred qualifications for this role include, but are not limited to, the following:
Engineering experience in a manufacturing environment
Experience with writing technical documentation, protocols, and reports
Experience developing and conducting manufacturing validations
Experience with quoting new materials and components with suppliers
Experience with ERP systems within a manufacturing environment
Experience with GD&T & BOM structure and set-up
Experience in regulated industry, with a preference for medical device
Experience working in project team settings or working in a matrix organization
Experience MS Project or other Gantt tracking software
Preferably located within travelling distance to San Antonio, TX office
Milestones
Milestones to be completed within one year of initiating contract are outlined below. Quarterly reviews to monitor progress towards goal will be conducted.
Completion of supplier selection, set-up, and sourcing risk assessments to support project
Completion of item set-up and engineering BOM creation to support development activities
Initiation of soft-tooling for project concepts and designs
Manufacturing line development to support engineering builds
Support of design verification builds with manufacturing team
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.