Sr Process Engineer - Exempt
- Danvers, MA
- $60.00-65.00 per hour
- Permanent
- Full-time
A Day in the Life
Be a part of a dynamic team that designs and develops manufacturing processes for new delivery systems from concept through design transfer and product launch. Our process development team is committed to revolutionizing the way we manufacture delivery systems, ensuring high-quality outcomes for our patients and customers.The ideal candidate will be a seasoned professional passionate about advanced manufacturing and the development of manufacturing processes during product development phases. You will work independently with limited supervision to determine and develop approaches to solutions. You will coach and review the work of lower-level professionals and may manage projects/processes. Your role will involve collaboration and dynamic interactions with R&D and Design Assurance regarding products in the development pipeline and with operation team members for new or iterative product implementation.
Responsibilities
- Lead the exploration and development of new process technologies that may be incorporated into new product development projects or existing manufacturing lines. Provide in-depth analysis and recommendations on process improvements.
- Lead new product development by designing and developing manufacturing processes for new products that facilitate ease of manufacturing while producing quality, cost-effective products with optimized yields.
- Work with the engineering team on studies to characterize process inputs to drive development of critical manufacturing/process specifications that are robust and meet quality expectations. Use appropriate statistical support and Design of Experiments (DOE).
- Identify equipment and fixture needs within pilot line and/or manufacturing operations.
- Generate required documentation in support of manufacturing products and processes, including engineering protocols/reports, PFMECAs, and manufacturing instructions. Ensure compliance with internal procedures, GMP, and regulations.
- Generate and execute plans for equipment qualification and process validation. Lead test method development and validation where needed.
- Bachelor's Degree in a related engineering discipline (i.E., mechanical, biomedical, industrial, materials science) with 4-7 years of experience or Advanced Degree with 4 years of experience.
- Previous medical device experience.
- Demonstrated problem-solving and critical thinking experience.
- Solid oral and written communication skills, including presentation skills.
- Solid interpersonal skills and ability to work in a cross-functional team environment.
- Solid understanding of statistical techniques and analysis.
- Design for Reliability and Manufacturability (DRM) experience.
- Demonstrated computer skills such as Minitab, Excel, Word, and Project.
- Process Validation (IQ/OQ/PQ) and Test Method Validation experience.
Together, we can change healthcare worldwide. We push the limits of what technology, therapies, and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)