Job Description ROLE AND RESPONSIBILITIES Primary responsibilities include overseeing product manufacturing operations and supervision of contract manufacturing partnerships to insure timely delivery, production, quality, compliance, and regulatory guidelines are met. The Project Management Engineer will own all the document and record retention responsibility and traceability responsibility and ownership that all aspect of the development, design, production, and delivery of the product is done so in a way that meets safety and regulatory standards while also meeting business objectives and timelines. This position will also own the execution and management of any partnership contracts with contract manufacturers to ensure that the business goals and integrity of Halo products are met. Key responsibilities would include:
• Management of Hospital Business contract manufacturing partners. • Overseeing delivery of required documentation for Hospital Business distribution partners as it relates to quality, engineering, specification, and regulatory requirements. • Routine auditing of contract manufacturing facilities. • Assurance that design documentation and traceability of all design changes are in place • Quality Improvement responsibility • Cost containment and continuous improvement • Successful development, integration, maintenance, and ongoing accountability of the quality management system (QMS). • Working with management and sales to adapt VOC into design modifications in a timely and efficient manner • Ensures that validation and qualification activities are consistent with company validation policies and procedures and federal regulations. • Ensuring that regulatory standards are in place, documented, and continuously updated. • Overseeing performance and safety testing required to ensure the integrity of the Halo product and brand. • Overseeing and managing quality and complaint systems with contract manufacturing partners on commercial products with our end-user customers. This would include establishing clear documentation of processes, communication, and seamless delivery and turn-around of product to Halo’s end-users. • Utilizes engineering product development/process knowledge to solve straight forward problems (e.g., FMEA, Process Modeling, Design of Experiments, SPC) • May provide Quality support for NCMR, Complaints, internal and external audit findings and CAPAs
QUALIFICATIONS AND EDUCATION REQUIREMENTS B.S. or Higher Degree in Mechanical Engineering Certificate in Project Management Preferred Must have experience writing master validation plans & writing procedures. 10 years or more experience in medical devices 7+ years’ experience in operations, quality management, compliance, regulatory, or combination of these are required Working knowledge of FDA regulatory requirements for Class II Medical Devices Working knowledge of requirements for CE marks and global registrations Experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485, and ISO 14971) and working knowledge of current and applicable GMP regulations is required Process Monitoring Validations, Risk Management, Sampling Plans, Statistics
PREFERRED SKILLS Strong Interpersonal Skills Strong Leadership Skills Ability to work with Cross Functional Teams including operations, Sales, and Executive Leadership Strong Presentation Skills Strong Verbal Communication Strong Problem-Solving Skills Ability to work remotely and independently with little supervision Ability to travel up to 20% of the time
About HALO In 1991, Bill Schmid and his wife Cathy suffered an unspeakable tragedy when they lost their infant daughter, Haley, to Sudden Infant Death Syndrome (SIDS), which is the sudden, unexplained death of a seemingly healthy infant up to an age of one year. After the loss of his daughter, Bill began an exhaustive review of the latest medical research and health recommendations for creating a safe sleep environment for babies to help ensure other families would not have to endure the same tragedy.
As a professional engineer, Bill devoted himself to finding new and creative ways to address sleep environment risks, which are primarily centered around loose bedding. Bedding can accidentally cover a baby’s face and interfere with breathing. With these risks in mind, Bill formed HALO Innovations and created the HALO SleepSack Wearable Blanket, which is intended to eliminate the likelihood that a baby can get entangled with clothing and loose bedding during sleep. The SleepSack wearable blanket is sleeveless and is worn over pajamas or a bodysuit to take the place of loose blankets. Since its launch, the HALO SleepSack brand has become the nation’s bestselling wearable blanket for babies and is widely used by hospitals nationwide.
To fulfill our mission, we listen, re-think, and use smart innovation to develop safer and better products for babies and children. This is most evident in the development of our Bassinest Swivel Sleeper for the hospital and at home. This revolutionary bassinet moves to allow parents to sleep close to their baby, while still maintaining a safe sleep environment for their child, reducing the risks associated with bed-sharing.