Senior Manufacturing Engineer

Develops and implements optimal, cost-effective manufacturing processes and methods in accordance with customer specifications and quality standards. The individual will provide process development and manufacturing engineering support as a project team member during product development phases and a project team lead during manufacturing scale up regarding the introduction of new products into manufacturing through DV builds, Clinical builds and/or Commercial builds. Individual will support commercial builds and recommend/implement improvements to production processes, methods, and controls.

• Applies sound engineering judgment to problems, which may include moderate complexity and conflicting design objectives or difficult materials.
• Participate as a team member on new product development projects as the manufacturing representative to provide DFM input and preliminary process development.
• Plans and coordinates projects of moderate scope to support manufacturing scale up including estimating schedules, staffing needs, project cost and budget.
• Assumes technical ownership for assigned products and projects.
• Responsible for equipment, tooling, and fixture design, development, and procurement including preparing specification’s and tests materials.
• Responsible for drafting process risk documentation including but not limited to Master Validation Plans and PFMEAs.
• Develop and oversee the execution of process validations including but not limited to IQs, OQs, PQs, Gage R&Rs, and other engineering studies, qualifications, and/or DOEs.
• Represents the company on technical issues and requirements to the customer. Adapt and devise new approaches to difficult problems from standard or known techniques.
• Makes independent decisions on work.
• Develops processes that meet safety regulations and adhere to ISO 13485, QSR 21 CFR 820, GMP, and other applicable requirements.
• Prepare and maintain detailed layouts of processes and related equipment.
• Coordinate launches of new processes including establishing goals, training team members, and evaluating results.
• Confer with management and other staff regarding manufacturing capabilities, production schedules, and other considerations to facilitate production.
• Supports on-going production to assure on-time delivery and company profitability.
• Apply statistical methods and perform process analysis for cost reduction, quality improvement and improved efficiency.
• Represents manufacturing engineering on cross-functional teams.
• Writes appropriation requests.

EXPERIENCE / EDUCATION:          

• Bachelor’s Degree in Mechanical Engineering highly preferred or the equivalent years of work experience.
• Additional training or certification in lean process and product development is ideal.
• Minimum six years’ previous experience in similar role required.
• Minimum six years' experience within the medical device industry preferred.
• Windows-based computer knowledge required.
• Knowledge of Design for Manufacturability (DFM) principles, biocompatibility requirements for materials, ISO13485 and US QSR 21 CFR, Part 820 Medical Devices, and basic understanding of the human anatomy preferred.
• Knowledge of various metal and polymer materials as well as testing specifications preferred.

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.

EEO Statement

Paragon Medical, a division of MW Industries, 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.