Paragon Medical helps accelerate new product development for ambitious medical manufacturers. Our experts have deep experience across a wide range of applications including implants, surgical instrumentation, single-use disposable devices, and many more. We produce everything from high-precision individual components and assemblies to complete end products, and we are currently looking for dynamic, innovative, and reliable team members to join our Paragon Medical family!

SUMMARY OF POSITION: Responsible for managing all aspects of a new product launch for surgical instruments, implantable devices, and delivery systems from opportunity review to production transfer. The position will lead customer and internal activities facilitating the product launch between the customer, supply chain, and Paragon.

ESSENTIAL FUNCTIONS:

• Manage Transfer & New Product launches.
• After project award, single point of contact for customer interface and Paragon collaboration, including primary technical representative for Paragon Medical with Client to negotiate product design and process deliverables. This position will be involved from concept to completion and may support project proposals, as necessary.
• Oversees quoting activities including the process outline and end-to-end costing process.
• Leads project requirement checklists through justification and/or rationalization of activities associated with product launch.
• Owns project planning and timeline execution, including managing project team workload, activities and scope.
• Responsible for monitoring and communicating product introduction schedules and plans.
• Leads Design for Manufacturability (DFM) with the Client and coordinates DFM discussions internally.
• Supports NPI engineering activities and oversees Device Master Record (DMR) development and accuracy with associated process development and testing.
• Supports pFEMA development and team discussions along with managing the risk mitigation activities and testing.
• Reports on project performance metrics.
• Leads pre/post-production meetings, including review of NPI lock down completion and obtaining optimum transfer of new product to the sustaining production team.
• Leads cross-functional teams to successfully complete assigned projects.
• May travel for customer support and partner with Business Development to solicit new program opportunities.
• Fosters close and productive relationships with cross-functional counterparts.
• Responsible for reporting/managing of timing, profitability, NRE investment and projects costs throughout the NPI process.
• Ensures accurate information is released to production to include, but not limited to, router, inspection sheets, in-process prints, and fixtures.
• Drives the implementation of the Project Management Group methodologies for the site.
• Works proactively with the team to share best-practices and lessons learned.

EXPERIENCE / EDUCATION:

• Bachelor’s degree in Engineering (Mechanical or Biomedical Engineering) or equivalent years of experience required.
• Minimum three years of experience in NPI projects (strategic/tactical planning and implementation capabilities) coupled with strong technical and conceptual aptitude required, preferably within medical device manufacturing.
• Minimum three years of experience in project management leading cross-functional teams and multiple projects.
• Demonstrated usage of project management tools.
• Experience with tight tolerance methods in machining and measurement system applications, blueprint reading, GD&T, working knowledge of short-run process control methods, statistical analysis, DOE, ISO standards and FDA quality system regulations.
• Previous experience in similar leadership role is strongly preferred.
• Windows-based computer knowledge is required.
• Knowledge of Design for Manufacturability (DFM) principles, biocompatibility requirements for materials, ISO 13485 and US QSR 21 CFR, Part 820 Medical Devices, and basic knowledge of the human anatomy strongly preferred.
• Knowledge of various metal and polymer materials, as well as testing specifications, strongly preferred.

SKILLS:

• Strong organizational, follow-through, and attention to detail skills required.
• Strong communication skills (oral, written, and presentation) required.
• Ability to handle multiple priorities simultaneously.
• Self-starter/motivator for personal and professional growth.
• Ability to form partnering relationships with peers and multiple levels throughout the organization.
• Understanding of geometric dimensioning and tolerance (GD&T) requirements for application to design projects.
• Ability to apply strong engineering principles, theories, concepts and techniques to tasks and projects that may result in new application and industry standards or practices.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:The physical demands and work environment characteristics described here are representative of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

· Physical demands: While performing the duties of this job, the employee is required throughout the workday to stand; walk; sit; use hands to handle objects; reach with hands and arms; stoop; talk or hear. Specific vision abilities required by the job include close vision and may also include color vision; depth perception; and the ability to see print in various sizes and formats. May be required to climb stairs, kneel or crouch. May be regularly required to pull and push up to 15 pounds and occasionally lift boxes up to 25 pounds.

· Work environment: Work performed in an office environment. The noise level in the work environment is usually low.

MW Industries, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Tuition reimbursement
• Vision insurance

Experience level:

• 3 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person
• Manufacturing facility

Education:

• High school or equivalent (Required)

Experience:

• Project management: 3 years (Preferred)

License/Certification:

• Certified Project Manager certificate (Preferred)

Work Location: In person

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