Sr Process Engineer

Top 3 technical skills that are required for the role:

1. Execute Robust Process Development utilizing DOE’s, IQ, OQ, PQ

2. Problem Solve

3. Ability to Write Detailed Work Instructions

Education Required: BS in Engineering Minimum

Years’ Experience Required: 4+

Will the contractor be working 40 hours a week? If not, weekly estimate?yes

Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like?Fully onsite

What is your timeline for scheduling interviews?ASAP

What product line will this person support?Cruiser, 014, Elastane

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. Danvers, the trusted partner for development and scaling of leading-edge delivery systems, transforming pellets into unparalleled performance and enabling the companyto serve more patients worldwide.

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. This process development team is committed and driven in our mission to revolutionize the way we manufacture delivery systems while producing a high-quality product for our patients and customers.
The ideal candidate will be a seasoned professional with a passion for advanced manufacturing and the development of manufacturing processes during product development phases. The candidate will be involved with process development, setting up manufacturing operations, and interfacing cross-functionally with other key engineering expertise to develop a product.
In this role, you will part of a team but will be able to work independently with limited supervision to determine and develop approaches to solutions. You will coach and review the work of lower-level professionals. You may manage projects/processes. You will communicate with senior internal and external customers and suppliers. Your work 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. Problems and issues faced are difficult and may require understanding of multiple issues, job areas or specialties.
Responsibilities may include the following and other duties may be assigned:
Process Technologies: Lead the exploration and development of new process technologies that may be incorporated into new product development projects or existing manufacturing lines. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
Process Development: 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. Such activities include, but are not limited to, the following:
• Manufacturing Studies: Work with engineering team on studies to characterize process inputs to drive development of critical manufacturing/process specifications that are both robust and meet quality expectations Use appropriate statistical support and Design of Experiments (DOE).
• Equipment and Fixture Development: Identify equipment and fixture needs within pilot line and/or manufacturing operations.
• Documentation: Generate required documentation in support of manufacturing products and processes. These include engineering protocols/reports, PFMECAs and manufacturing instructions. Ensure compliance with internal procedures, GMP and regulations.
• Qualification and Validation: Generate and execute plans for equipment qualification and process validation. Lead test method development and validation where needed.

Must Have: Minimum Requirements
• Bachelors 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
Nice to Have
• 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.