Manage all Development activities within an assigned project from product conception through market launch.
Essential Duties and Responsibilities include the following.
- New product development and new product introduction of FDA, ISO 13485, CE, ISO 14971, MDD 93/42/EEC, MDR compliant medical devices.
- Accountable for design history file and technical file documentation and other controlled documents under regulatory framework.
- Estimate capital and engineering expense budgets required for different phases within the Project, and adjust estimates when required.
- Ensure projects stay on time, on task, and on budget through timely project reporting and communications.
- Drive the completion of assigned deliverables with individuals assigned to the Project that are not direct reports.
- Own the entire process to production readiness including coordination of procurement, quality and assembly. Job is complete once Project reaches stable operations. =.
Education and/or Experience
- Bachelor's degree (BSME) from a four-year college or university with 7+ years experience in project management in a manufacturing environment that produces medical devices.
- Demonstrated product design transfer (NPI) proficiency on successful new product introductions.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Strong Project Management skills and experience.
- Working knowledge of SolidWorks as it pertains to mechanical system layout
- Working knowledge of GD&T/ANSI standards.
- Proficiency with Microsoft Office products.
- Should have exposure to manufacturing processes like sheet metal, drilling, machining and welding.
- Excellent communication and presentation skills to a wide range of management levels including high level company and customer personnel.
- Proven ability to execute Product Development Projects.
- Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents.
- Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community.
- Ability to effectively present information to top management, public groups and/or boards of directors.
- Ability to comprehend and apply principles of advanced calculus, modern algebra and advanced statistical theory.
- Ability to work with mathematical concepts such as probability and statistical inference and fundamentals of plane and solid geometry and trigonometry.
- Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations. Ability to create and calculate financial models for program development projects, including Net Present Value, Payback, Internal Rate of Return.
- Ability to define problems, collect data, establish facts and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Must have the ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
- Must be able to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases.
- Must be able to deal with a variety of abstract and concrete variables.
Ferno is an equal opportunity employer and that all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status.
Job Type: Full-time
- 401(k) Matching
- Dental Insurance
- Flexible Schedule
- Flexible Spending Account
- Health Insurance
- Life Insurance
- Paid Time Off
- Tuition Reimbursement
- Vision Insurance
Supplemental pay types:
- Medical Device: 2 years (Required)
This Job Is Ideal for Someone Who Is:
- People-oriented -- enjoys interacting with people and working on group projects
- Adaptable/flexible -- enjoys doing work that requires frequent shifts in direction
- Detail-oriented -- would rather focus on the details of work than the bigger picture
- Innovative -- prefers working in unconventional ways or on tasks that require creativity
- Only full-time employees eligible
Work Location: One location