Senior Mechanical Engineer (Onsite)

Position Overview:
 

Insulet is the world’s leading manufacturer of high-volume, disposable, electromechanical, wearable medical devices.  As a Sr. Mechanical Engineer in the Global Equipment Engineering Group, the candidate will support both current manufacturing operations as well as new product development by providing expertise related to the continuous improvement efforts for existing manufacturing processes/equipment.  The candidate will also work with internal customers and external vendors to specify, procure, and install new manufacturing lines and equipment in accordance with business needs.  The candidate will work in a collaborative teaming environment and be responsible for working with peers within Insulet, as well as with its suppliers and customers to ensure that Insulet is sourcing components that meet the specified quality standards.  Responsibilities include working with the cross-functional team(s) and / or strategic partners and providing technical guidance on metrology related topics.  This is a challenging role, suitable for an energetic problem solver who has solid technical, organizational and communication skills.

Responsibilities:

The successful candidate will primarily focus on the design, development, specification and implementation of automated equipment for assembly and packaging processes.  In addition, continuous improvement efforts, obsolescence programs, technology transfers and new product development may also be exercised in support of business objectives.  Important job qualifications include:

• Lead the commissioning, qualification (IQ/OQ/PQ), and ramp-up of a new automation line for medical device assembly.

• Perform on-site support in Malaysia for a minimum of 12 months to oversee equipment installation, debug, validation, and line stabilization for new Line startup. Act as the primary liaison between global equipment engineering and the local manufacturing site, ensuring alignment on technical deliverables, timelines, and quality standards.

• Collaborate with cross-functional teams including manufacturing, quality, maintenance, and supply chain to ensure successful production readiness.

• In depth and prolonged experience in specifying, selecting, manufacturing acceptance, installation, startup, commission, and validation of fully automated and advanced discrete component assembly and / or packaging technologies is sought.  Sound mechanical skill set incorporating machine design Projects and a strong mechanical aptitude is required. 

• Technical mastery in mechanical engineering, namely assembly technologies and packaging (i.e. blister forming, cartoning, bagging, sealing etc.), is preferred.  Technical mastery in the following areas is sought:

  • Hands-on mechanical aptitude and Machine Design including pneumatics, linkage design, mechatronics, robotics, and drive systems.

  • Process Technologies: ultrasonic welding, heat transfer decoration, hot stamping, laser welding, laser decoration.

  • Packaging: material knowledge, cartoning, conveyor systems and sealing technologies.

• The demonstrated ability to understand user requirements of complex types of products, translate these into a complete conceptualized automated value stream solution; Creates or coordinates the design solutions for novel or complex problems; integrates regulatory and operational needs, and assesses cost benefit.  Having done so in a regulated and/or medical device industry is a plus.

• The management and oversight of vendor communications and collaboration is required.  Ability to critically review engineering designs and ensure adherence to company design and development guidelines and SOPs.  Proven ability to manage multiple projects is a plus.  Ability to successfully lead teams and vendors to achieve exceptional results.

• Responsible for managing the IQ, OQ, FAT, SAT and PQ efforts for new assembly and packaging technologies and / or transferring technologies to new factory sites. 

• The individual must be able to build the capability of others to assure successful project execution.  Engages and energizes others to reach their fullest potential and performance.  This can include, but is not limited to improving business process systems, developing training aids and SOPs, and providing feedback to discipline owners for future designs.  In addition, knowledge and experience with post-implementation continuous improvement efforts and methodology is beneficial.

• Candidate should have good problem-solving skills and be capable of responding to barriers, problems, and challenges with internal manufacturing or external equipment suppliers. Needs to be able to effectively deal with conflict and openly comm