Manufacturing Technical Writing Specialist (On-site)

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

Position Overview:

The Manufacturing Technical Writing Specialist will be a critical contributor in a mission that truly represents a once-in-a-lifetime opportunity to join a company that is making significant investments in establishing US manufacturing, expanding internationally, and delivering a consistent cadence of product innovations to the market and investing in its people. The successful candidate will be responsible for researching, authoring, editing, and publishing manufacturing assembly and test procedures for the team to ensure the successful production of our signature product. Work with manufacturing technicians and engineers to understand process details and requirements needed to achieve manufacturing goals. This position requires strong oral and written communication skills, mechanical aptitude, technical ability, and problem-solving skills, ability to read and understand a variety of documents pertaining to manufacturing, including but not limited to; blue-prints, schematics, maintenance manuals, bills of laden, and quality documentation. This individual must possess a willingness to work in a fast-paced manufacturing environment.

Responsibilities:

· Work with various subject matter experts across disciplines including manufacturing operations, quality assurance, supply chain, and engineering to develop and own content on various manufacturing and quality functionalities

· Tracking, auditing and reporting of posted documents within the manufacturing environment

· Tracking, auding and reporting of good documentation practices within the manufacturing environment

· Develop digital documentation in line with existing style and documentation platforms

· Creating or updating technical documentation and procedures to reflect solutions for mechanical errors, safety issues or general operating inefficiencies within the production processes

· Safely follow standard operating procedures including material handling, record keeping, packaging, and shipment preparation. Must follow all Good Manufacturing Practices (GMPs)

· Observe production, developmental and experimental activities to determine operating procedure and detail.

· Excellent attention to detail, good organization, and capable of working independently with minimal supervision from manager

· Able to work in small groups and cross functional teams to maximize process efficiency

· To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. In addition to the above, requirements listed below are representative of the knowledge, skill, and/or ability required

Education and Experience:

Minimum Requirements:

· Bachelor's or equivalent experience

· Minimum of 1 - 3 years of experience in Medical Device manufacturing or cGMP regulated industry

· 1 year of experience writing technical documentation sufficient to meet or exceed regulatory requirements of medical device manufacturers

Preferred Skills and Competencies:

· Strong organizational and written communication skills

· Ability to make decisions and work with minimal to moderate supervision.

· Proficient in all MS Office applications

· Mechanical aptitude

· Previous experience authoring and publishing controlled documentation

· Experience working within a PLM system (Arena preferred)

· Strong planning, organization, and multitasking skills

· Hands-on experience working in a manufacturing environment

· Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.

· Previous experience working in a clean room environment.

· Previous experience with technologies such as laser welding, heat staking, ultrasonic welding, and ESD-sensitive devices.

· Familiarity with manufacturing instrumentation such as optical gauging, video microscopes, micrometers, calipers, feeler gauges, dial indicators, and gauge blocks.

· Mechanical Aptitude – Knowledge of and experience with automated machines and tools, including design, uses, repair, and maintenance.

· Production & Processing – Knowledge of raw materials, measurement instruments, production processes, quality control, and other techniques for the manufacture and distribution of goods.

· Mathematics – Knowledge of basic arithmetic, algebra and/or geometry.

· Problem Solving – Recognizes problems and understands root cause analysis techniques/concepts.

Physical Requirements (if applicable):

· Required to stand for at least 10% of working time per shift, with walking at least 10% of working time per shift.

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite 

Additional Information: