Senior Product Development Manufacturing Engineer
Full Time • Foxborough
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
COMPANY OVERVIEW:
Sage Product Development, Inc. provides fast, efficient and creative product development and low to mid volume production services to medical device companies. We are a focused team of experienced medical device engineers who know what it takes to develop successful products for startups, multinational companies, and everyone in between.
We combine a high level of experience with a low overhead company structure. We solve client companies’ technical challenges and meet their product development needs in a timely, efficient and highly personalized manner.
We offer the right candidate the opportunity to work in an entrepreneurial environment, enhance their engineering design transfer to manufacturing abilities, and build their network within the industry.
GENERAL SUMMARY:
- Develop medical devices from concept through market introduction on a contract basis for client companies.
- Meet or exceed customer expectations.
ESSENTIAL JOB FUNCTIONS (all as required by client companies):
- Lead projects to manufacture medical devices. Direct the work of manufacturing technicians.
- Provide manufacturing engineering expertise to product development projects. Contribute to the product development process by utilizing Design for Manufacturing, Design for Assembly, 5S, lean engineering, six sigma, or other methodologies.
- Generate and maintain Process FMEAs.
- Complete IQ/OQ/PQ activities as required
- Generate and maintain assembly procedures and routings.
- Guide post-verification projects through design transfer in manufacturing
- Design and develop medical devices (disposable and reusable), catheters, equipment, implants, and/or packaging, from concept through market introduction. Ensure that designs meet performance specifications, regulatory and manufacturing requirements.
- Manage product development projects. Prepare project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs. Proactively communicate task assignments to responsible individuals, and ensure that tasks are completed within the planned time. Track projects to project plans. Proactively report project status to Sage personnel and to the project’s client company.
- Interact with client companies in a professional manner. Proactively communicate with client companies to ensure an ongoing two-way exchange of information.
- Design and implement new methodologies, materials, machines, processes or products as required to achieve product development goals.
- Conduct risk analyses. Conduct and document Failure Mode and Effects Analyses.
General:
- Interact with client companies and Sage team members in a professional and courteous manner. Proactively communicate with client companies to ensure an ongoing two-way exchange of information.
- Prepare daily timesheets and submit completed timesheets on a weekly basis.
- Prepare documentation release and change packages for production documentation. Approve Document Change Orders (DCOs) and obtain approvals from others as required.
- Ensure that all work satisfies the requirements of Sage’s or the client companies’ Quality Systems with particular emphasis on Design Control.
- Some local travel (i.e. by car). Occasional long-distance travel (i.e. by plane).
OTHER DUTIES AND RESPONSIBILITIES
- Any other duties as assigned.
REQUIRED COMPETENCIES
Customer Focus
- Provide professional, reliable and prompt service to client companies and coworkers. Work in partnership with others to meet or exceed customer expectations. Interpret customers’ needs and take appropriate action. Follow through on customers’ inquiries in a professional and timely manner.
Management of Resources
- Work in an organized and time effective manner. Proactively seek out relevant reference materials as necessary. Take initiative for self-development. Prioritize tasks effectively. Demonstrate initiative and innovation in the use of available resources.
Communication Skills
- Write and speak in a concise, technically accurate, timely, and professional manner. Exhibit strong verbal presentation and negotiation skills. Interact with client company personnel in a positive and professional manner. Express ideas, recommendations and solutions clearly, logically and concisely in both written and verbal communications. Demonstrate tact and diplomacy in communications. Demonstrate active listening skills and ability to resolve discrepancies with customers.
PREPARATION, KNOWLEDGE, SKILLS & ABILITIES:
- Bachelor's degree is required, preferably in Mechanical, Biomedical or Industrial Engineering. Master’s degree in engineering, management or business is a plus.
- Medical device product development and manufacturing engineering experience is required.
- Minimum 3 years of product development design transfer to manufacturing experience is required.
- Ability to interact with client companies in a professional manner.
- SolidWorks 3D CAD proficiency is required.
- Knowledge of probability and statistics, proficiency in Minitab software is a plus.
- Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.
SUPERVISORY RESPONSIBILITY:
- May direct the work of other people and may have direct reports.
REPORTS TO:
Engineering Managr
Engineering Managr
WORKING CONDITIONS/PHYSICAL DEMANDS:
- Must be able to move throughout manufacturing, office and laboratory space, using a complete variety of office equipment, machinery and tools. Must be able to lift more than 25 pounds and stand for extended periods of time.
- Must be able to wear cleanroom gowning items (head cover, coat, gloves, shoe covers, facial covering if needed) and work in cleanroom environment for extended periods of time.
- Must be able to work with chemicals found in a manufacturing environment.
- The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job. The above is not intended to be an exhaustive list of all responsibilities and duties required.
- External and internal applicants, as well as position incumbents who become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case by case basis.
No Third-Party Agencies
We kindly request that recruitment agencies, staffing firms, and outsourcing companies do not contact us regarding this or any other posted position. All candidates must apply directly to be considered. Unsolicited resumes from third parties will not be accepted and will become the property of Sage Product Development, Inc.
Compensation: $100,000.00 - $140,000.00 per year
Who We Are
Sage’s diverse group of industry professionals is committed to making medical device development or manufacturing project a success. We combine a high level of experience with a low overhead company structure to solve technical challenges and meet product development needs in an efficient, highly personalized, and cost-effective manner.
It's in our DNA
Our team is led by engineers with decades of experience who are recognized as medical device design and development experts. Their knowledge and skills are integrated with the energy and youthful outlook of those earlier in their careers. We are known for the creativity, flexibility, and quality of our mechanical engineering, bioengineering, industrial design, quality assurance, and manufacturing capabilities.
Let’s Create Something Together
Passionate about product development? Are you excited by the prospect of bringing innovative medical devices to market to help people? If you think you’re a good fit, we’d love to hear from you.
Grow with Sage
We are a team of creative engineers who are passionate about helping client companies succeed. By maintaining a culture of honesty, integrity, openness, optimism and flexibility we build strong working relationships with client companies and with each other. We enjoy the work we do, and we have fun doing it, while always keeping in mind the ultimate goal of improving the lives of patients and clinicians.
Apply here.
