iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmias are clinically diagnosed by combining our wearable bio sensing technology with powerful cloud-based data analytics and Artificial Intelligence capabilities. Our goal is to be the leading provider of ambulatory ECG monitoring for patients at risk for arrhythmias. iRhythm’s continuous ambulatory monitoring has already put over 2 million patients and their doctors on a shorter path to what they both need – answer.
About this role:
iRhythm is currently seeking an experienced Senior NPI Manufacturing Engineer with a proven record of accomplishment transferring medical to manufacturing. You will be part of a team developing a new pilot manufacturing line focusing on high throughput, low manufacturing cost, and high reliability. You will also help translate the learnings from the pilot line into a high volume production line. The Product Development team is made up of a close-knit group of talented engineers representing a wide range of engineering disciplines. We work together in a collaborative atmosphere and we are passionate about delivering innovations that improve the quality of health care and the patient experience. Our work environment is fast-paced, with a collaborative atmosphere. Most of all, we are passionate about delivering innovations that improve the quality of health care and the patient experience. We are looking for like-minded individuals to join our team today!
Specific job responsibilities include:
- Provide a key interface between the product development team and the manufacturing team for design transfer.
- Collaborate with all shareholders to create an efficient pilot manufacturing assembly line, developing assembly strategies, specifying workflow processes, manufacturing plan, and detailed work instructions.
- Provide technical leadership to less senior team members
- Manage tech transfer projects
- Determine the optimum level of automation to meet production volumes and quality.
- Design, procure, qualify, implement, and document fixtures, tools, and equipment.
- Develop strategies and workflow to integrate labeling/serialization into products.
- Engage and coordinate activities of external vendors to implement new production line equipment and processes.
- Work closely with manufacturing personnel to incorporate their user needs and feedback into the design of tools and workflows.
- Analyze manufacturing line and resulting product from a risk perspective (PFMEA).
- May be involved with validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/PQ).
- Provide volume production support through successful and sustained project launch.
- Support identification of and implementation of continuous improvement projects with respect to yield, cycle time reduction, product reliability, capacity enhancement, ergonomic improvement, and cost reduction.
- Provide technical support analyzing and/or performing failure analysis for discrepant production components, assemblies and field returns.
- Bachelor's degree in Mechanical Engineering or equivalent technical discipline, with 10 -15 years of relevant work experience in a manufacturing environment.
- Management or technical leadership experience
- High volume single use/disposable medical device or similar regulated product manufacturing experience involving small injection molded housings, electronics, adhesives, and related assembly and test sequences.
- Must possess strong communication skills to interface with production line personnel, technicians, product development engineering, QA, and management.
- Prior experience designing equipment/tooling/fixtures for high throughput.
- Knowledge of basic statistics
- Able to travel 25% of time to production manufacturing facilities in Orange County.
- Self-motivated and disciplined to meet deadlines in the context of competing priorities and projects
- Understanding of the manufacturing process in a regulated industry or other quality-centric environment, and the related documentation requirements.
- PREFERRED: Experience using data acquisition software such as Labview and statistical software packages such as MiniTab or JMP, SolidWorks or similar
What’s in it for you:
This is a full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurance (all of which start on your first day), paid holidays, and PTO!
iRhythm also provides additional benefits including 401K (with company match), an Employee Stock Purchase Plan, paid parental leave, pet insurance discount, Cultural Committee/Charity events, and so much more!
FLSA Status: Exempt
As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer (M/F/V/D). Pursuant to San Francisco Fair Chance Ordinance, we will consider for employment all qualified applicants with arrest and conviction records.