Medical Hardware Sr. Product Engineer
Full Time + Benefits
Fralock is a well-established manufacturing company, based in the Santa Clarita Valley, that has a 50 year history of excellence. We are growing rapidly and have a Medical Hardware Sr. Product Engineer position at our Careers Technology location in Chatsworth, CA.
We are looking for people who exemplify strong work ethics, values, dedication and character with the ability to make independent, intelligent decisions. If you thrive in a fast paced environment, which is focused on exploring and developing the next generation technology while offering opportunities for advancement, apply today.
We offer Paid Vacation/Sick/Holiday, 401K after 1 month of employment, annual bonus program (conditions apply), Medical/Vision/Dental coverage growth opportunities, training assistance programs and many more!
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Culture Vision: Our results driven team strives to deliver extraordinary outcomes through our passionate commitment to each other, collaboration, courage and innovation
1. Medical hardware industry expert to support Medical Segment team in new business development. Able to translate voice of customer in product definition and provide ongoing support to strategic customers.
2. Work with design engineers to develop and support production release of new products/concepts/designs answering to Medical requirements, expressed or implied.
2. Become a SME of the current manufacturing processes, including integrating expressed or implied requirements from Medical customers (biocompatibility, reliability, function, etc…)
3. Be the contact point to support in a timely manner any Fralock department facing a Medical customer opportunity, problem, including performing root cause analysis, containment actions, corrective actions, etc…
4. Manage, supervise or realize part of product life cycle gate process including process description, instructions and training required to complete.
6. Ability to provide ROI analysis of alternate products, methods, processes, or equipment, and create executive summaries
7. Ability to realize and implement Design of Experiments
This position requires access to information controlled under the International Traffic in Arms Regulations (ITAR) or the Export Administration Regulations (EAR), the successful candidate must be a "U.S. person" as defined in the ITAR and EAR (which generally means (i) be a citizen or national of the United States; or (ii) be a lawful permanent resident of the United States; or (iii) have been admitted to the United States as a refugee, or have been granted asylum, as specified under applicable law.
1. Responsible for improving product performances and field of applications.
3. Provide technical support to sales team during customer meetings.
2. Work on product design and development for existing and new products, which includes choosing the right material, stack, design, and manufacturing process.
3. Research future, new and existing equipment/machines/technologies to ensure strategic product development will match existing market evolution and open future/lateral markets.
4. Work on projects that will reduce lead times, internal manufacturing costs, and will improve process control and yield.
5. Lead realization of work instructions and training.
6. Work within QA/QC procedures with an ability to understand their scope and application, as well as waiver documentation and procedures.
Strong knowledge and experience of hardware engineering for Medical solutions including (implantable devices, catheters, endoscopes, defibrillators, pacemakers, MRI/CT, Ultrasound, cochlear, PCR, wearable devices and materials,…)
Strong computer skills
Excellent verbal and written communication skills
Ability to analyze data and problem solve
Read and interpret engineering drawings
Valid driver's license, insurance, and acceptable driving record
Self motivated, results and action oriented, and a strong team player
A hands on aptitude (process, mechanical, electrical, DIY)
Knowledge of Lean Manufacturing, Just In-Time, Kanban principles
Process Engineering Knowledge
Understanding & Implementation of IQ-OQ-PQ & PFMEA
Knowledge of ISO 9001, AS9100 or ISO 13485
Class III Medical Manufacturing Standards
Knowledge of Salesforce
Bachelor degree in engineering or any related field
7-10 years of Medical experience and preferably experience working with major OEMs such as Medtronic, Abbott, GE, Philips, Siemens, Thermofisher
Able to ascend/descend stairs while carrying acceptable loads
This position must pass post offer drug test, Pre-work Screen, Integrity, and background check. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of a position.