Manufacturing Engineer
Company Description
At Biomeme we make things. We make hardware; we work with biological organisms; we hack smartphones. We're looking for passionate people who are skilled with their hands and have impeccable attention to detail. You should be a fast learner and not afraid of tackling challenges both big and small. No task is above or below your pay grade.

Biomeme is as interdisciplinary as it gets. We combine rigorous biology and chemistry with best-in-class hardware and software engineering. It's all wrapped up in sublime user design, with the goal of helping our customers enact real-world change. Guided by data and a belief in the iterative process, we develop elegant solutions to complex problems that demand precision.

Our partners and customers span a wide range of industries across the US, Latin America, Africa and Europe. We've got great traction in health: we're testing for STD's in Philadelphia, Malaria and Ebola virus in Africa, Avian Influenza in Europe, veterinary targets in the Andes and Lyme disease in the US. Outside of health, we have partners in industrial water monitoring, aquaculture, agriculture, conservation biology and more. High school students are testing for mislabeled sushi. Quantified Selfers are tracking their microbiome. Everyday users are even testing their own DNA for genetic markers.

We also recently began work on a multi-year, multi-million-dollar contract with the US Government. It's a good time to come onboard.

Location
Center City, Philadelphia, PA 19107
Employment Type
Full Time
Experience
Mid/High Level
Job Description
We’re looking for a talented Manufacturing Engineer to lead the build up our production facility here in Philadelphia. Focus will be on ramping production of our diagnostic kits. Currently we’re low volume but will be scaling up soon. This work will require knowledge of plastics bonding and sealing, liquid dispensing, and packaging. Responsibilities will include the R&D of manufacturing tools and training personnel for manual packaging with an eye toward automation as needed. Our products are unique and early phase manufacture of these kits requires a flexible problem-solving approach with an appreciation for iterative design. Candidate with a proven track record solving complex technical issues is needed. These kits will need to comply with quality standards of the medical device industry so experience establishing ISO systems is preferred. 7-10yrs or more experience in the field is preferred. Knowledge of USDA, FDA device/ diagnostics is a plus.

RESPONSIBILITIES:


• Develop new or improved manufacturing methods using existing and new equipment.
• Investigate, recommend, and justify new technologies, manufacturing methods and equipment to meet competitive business needs and improve efficiencies.
• Identify and work with vendors to arrange for purchase and installation of equipment, materials, etc.
• Analyze and design layout of equipment and workspace ensuring maximum efficiency.
• Develop methods for liquid filling and sealing of challenging chemistries. 
• Design custom tooling when required.
• Troubleshoot and correct system processes.
• Investigate options for new or improved tooling or tooling systems
• Document processes and train operators and other personnel.
• Create and revise documents such as Work Instructions, Training Guides, and Preventative Maintenance.
• Assist in developing and conducting protocols including IQ, OQ, and PQ activities as required
• Analyze process outputs using statistical methods to ensure stability of kits
• Build and grow our manufacturing organization in response to project load
• Oversee manufacturing operations internally and external manufacturing partners

QUALIFICATIONS
 

• Must have experience working with joining molded plastics, foils, films, liquid filling, sealing,
• Bachelor’s degree in Engineering from an accredited college or university or equivalent experience
• Experience in medical devices, pharmaceuticals, and/or product packaging preferred
• Proficient in Solid Works a must
• Knowledge of cGMP manufacturing requirements related to clinical production.
• Direct experience with manufacturing operations and biotechnology processes and/or a demonstrated track record of successfully executing within an FDA-regulated manufacturing environment is strongly preferred.
• Excellent leadership, communication and collaboration skills in a cross-functional and fast paced environment.

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